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  • Dispositivo 374
  • Fabricante 58
  • Evento 124969
  • Implante 1
Retiro De Equipo (Recall) de Device Recall Coulter LH 780 Hematology Analyzer
  • Tipo de evento
    Recall
  • ID del evento
    66826
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0471-2014
  • Fecha de inicio del evento
    2013-11-08
  • Fecha de publicación del evento
    2013-12-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123612
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Counter, differential cell - Product Code GKZ
  • Causa
    Beckman coulter is recalling the lh 750 and lh 780 hematology systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nrbc), white blood cell differential and/or reticulocytes.
  • Acción
    Beckman Coulter sent an customer notification letter dated 11/8/13 to all customers who purchased the LH 750 and LH 780 Hematology Systems. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to contact Beckman Coulter's Customer Support Center at http://www.beckmancoulter.com/customer/support or call (800) 526-7694 in the US and Canada. Outside the US and Canada, customers are instructed to contact Beckman Coulter Representative. On 2/17/14, Beckman Coulter expanded the recall to inform Coulter LH 750 and Coulter LH 780 Hematology Analyzer customers of the issue related to LH Cleaner and Coulter Clenz.
Retiro De Equipo (Recall) de Device Recall Navigator HD
  • Tipo de evento
    Recall
  • ID del evento
    66828
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0440-2014
  • Fecha de inicio del evento
    2013-11-05
  • Fecha de publicación del evento
    2013-12-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123623
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    endoscopic access overtube, gastroenterology-urology - Product Code FED
  • Causa
    The 13f/15f navigator hd ureteral access sheathset are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.
  • Acción
    Urgent recall notification letters were sent via Federal Express Priority mail on November 5, 2013. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in their inventory. Follow-up communications will be made to the accounts that do not respond to this inquiry.
Retiro De Equipo (Recall) de Device Recall Navigator HD
  • Tipo de evento
    Recall
  • ID del evento
    66828
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0441-2014
  • Fecha de inicio del evento
    2013-11-05
  • Fecha de publicación del evento
    2013-12-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123624
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    endoscopic access overtube, gastroenterology-urology - Product Code FED
  • Causa
    The 13f/15f navigator hd ureteral access sheathset are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.
  • Acción
    Urgent recall notification letters were sent via Federal Express Priority mail on November 5, 2013. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in their inventory. Follow-up communications will be made to the accounts that do not respond to this inquiry.
Retiro De Equipo (Recall) de Device Recall Navigator HD
  • Tipo de evento
    Recall
  • ID del evento
    66828
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0442-2014
  • Fecha de inicio del evento
    2013-11-05
  • Fecha de publicación del evento
    2013-12-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123625
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    endoscopic access overtube, gastroenterology-urology - Product Code FED
  • Causa
    The 13f/15f navigator hd ureteral access sheathset are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.
  • Acción
    Urgent recall notification letters were sent via Federal Express Priority mail on November 5, 2013. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in their inventory. Follow-up communications will be made to the accounts that do not respond to this inquiry.
Retiro De Equipo (Recall) de Device Recall EOS System X ray beam
  • Tipo de evento
    Recall
  • ID del evento
    66833
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0529-2014
  • Fecha de inicio del evento
    2013-11-07
  • Fecha de publicación del evento
    2014-01-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-01-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123687
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Causa
    Eos imaging discovered during production internal testing that the x-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the x-ray beam operated by the eos system during the x-ray acquisition.
  • Acción
    CDRH approves the following conditions for EOS Imaging SA: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator notes below what are to be included in the notification. The draft letter provided on November 28, 2013, is deficient for the following reasons: a. It does not provide a statement that all repairs will be made without charge (21 CFR 1003.21(3)). b. It does not provide instructions, with respect to the use of the product pending the correction of the defect (21 CFR 1003.21(1). Specifically, the letter should include directions for the user to determine if the collimation defect is currently present in their system, which would initiate immediate correction, rather than at the next semi-annual service. 2. The customer notification letter will be sent in the manner required by 21 CFR 1003.21(b). 3. The repairs outlined are to be completed by July 1, 2014. All systems under service contracts (which includes semi-annual service) would be visited between receipt of this letter and July 1, 2014. All repairs, including those to systems which are not under service contracts, are also expected to be completed by July 1, 2014. EOS may proceed with implementation of the CAP (subject to the conditions noted above. The customer notification letter may be sent out immediately upon addressing the above deficiencies. However, it is suggested that you provide a copy of the revised letter to FDA for approval prior to issuance. For further questions please call (678) 564-5400.
Retiro De Equipo (Recall) de Device Recall SIGMA LCS HIGH PERFORMANCE"
  • Tipo de evento
    Recall
  • ID del evento
    66864
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0423-2014
  • Fecha de inicio del evento
    2013-11-18
  • Fecha de publicación del evento
    2013-11-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123821
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Causa
    Depuy orthopaedics, inc. is issuing a voluntary device correction of the hp m.B.T. keel punch knee instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
  • Acción
    DePuy Orthopaedics sent an Urgent Information - Medical Device Correction letter to all affected customers on November 18, 2013. Immediately after initiation on November 18, the company halted initiation with our US distributors and international affiliates because the surgical technique referenced and images from the surgical technique were not correct. No surgeons received the November 18 surgeon letter. The recall was re-initiated on November 20, 2013. The communication to the surgeons who used the affected devices will be delivered by Distributors either by mail or in person and includes the surgeon letter. The device correction includes awareness, reiteration of surgical techniques and instrument care, and visual check of the device as outlined in the Field Notice and Surgeon letter. The devices are not being removed from the market, but the company is investigating potential design changes to the HP M.B.T. Keel Punch Knee Instrument to reduce the potential for the tabs to fracture. All DePuy United States Distributors and DePuy affiliate contacts for Canada, Latin America and International will be notified via email. The US Distributors will identify surgeons who use the affected instruments on Distributor Response Card #1. The US Distributor will notify surgeons either by mail or in person with the written communication. Once all device correction activities are complete, the US Distributor will complete and return Distributor Card #2 to DePuy Orthopaedics, Inc. The US distributors are the US consignees and are responsible for notifying all new HP M.B.T. Keel Punch Knee Instrument surgeon users of this device correction. All territories are required to ensure the HP M.B.T. Keel Punch Knee Instrument Device Correction is promptly initiated. Customers were asked to review the instructions included, along with the attached documents, which contain important information regarding notification of surgeons affected by this Device Correction. Customers
Retiro De Equipo (Recall) de Device Recall VerifyNow IIb/IIIa Test, 10Test Kit
  • Tipo de evento
    Recall
  • ID del evento
    66834
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0482-2014
  • Fecha de inicio del evento
    2013-11-14
  • Fecha de publicación del evento
    2013-12-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-12-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123688
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, automated platelet aggregation - Product Code JOZ
  • Causa
    Accumetrics is recalling the verifynow iib/iiia 10-test because it contains incorrect information for the amount of time in which to perform the test following collection of the patient sample. the correct instruction is to perform the test within 15 minutes of collecting the patient sample.
  • Acción
    Accumetrics sent an Urgent Medical Device Correction letter dated November 14, 2013 to end users for the VerifyNow IIb/IIIa 10-Test. The letter informs the customers of the problems identified and the actions to be taken. The customers are instructed to call Accumetrics Customer Support at (800) 643-1640 option 2 or email at support@accumetrics.com. Customers are instructed to complete and return the enclosed Customer Account Tracking Form as soon as possible. For questions regarding this recall call 858-643-1600.
Retiro De Equipo (Recall) de Device Recall Medtronic Advanced Energy Aquamantys3 Pump Generator
  • Tipo de evento
    Recall
  • ID del evento
    66835
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0905-2014
  • Fecha de inicio del evento
    2013-11-12
  • Fecha de publicación del evento
    2014-01-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123689
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Causa
    The internal protection circuitry on the electrosurgical output that prevents a patient from exposure to dc voltage when the device is activated is being compromised during normal use.
  • Acción
    Medtronic sent an Urgent Product Removal Notification on November 12, 2013, via Next Day FEDEX. The communication advises users to immediately stop using the affected AQM3 electrosurgical generators and quarantine them until they can be returned to Medtronic Advanced Energy. Medtronic field personnel will collect them in order to remove them from service and return them to Medtronic Advanced Energy. Customers with questions were instructed to contact Customer Service at 866-777-9400. For questions regarding this recall call 866-777-9400.
Retiro De Equipo (Recall) de Device Recall Timberline MPF Straight Split Tip Driver Short ("Dri...
  • Tipo de evento
    Recall
  • ID del evento
    66836
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0400-2014
  • Fecha de inicio del evento
    2013-11-04
  • Fecha de publicación del evento
    2013-11-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-12-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123690
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
  • Causa
    Lanx, inc. is recalling various lots of timberline mpf straight split tip driver - short ("driver") because the width of the most distal end from the driver handle (the tip of the hex portion of the driver) is oversized.
  • Acción
    LANX sent an URGENT: Recall letter dated November 5, 2013, to all affected customers via Federal Express, Overnight delivery. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all affected product to the firm. Customers with questions were instructed to contact Field Inventory Management. For questions regarding this recall call 303-501-8402.
Retiro De Equipo (Recall) de Device Recall Portex Arterial Blood Sampling Line Draw Syringes
  • Tipo de evento
    Recall
  • ID del evento
    66837
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1180-2014
  • Fecha de inicio del evento
    2013-11-22
  • Fecha de publicación del evento
    2014-03-12
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123691
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Tubes, vials, systems, serum separators, blood collection - Product Code JKA
  • Causa
    Issue with the plunger tip of the portex¿ arterial blood sampling line draw syringes.
  • Acción
    Smiths Medical sent an Urgent Field Safety Notice dated November 22, 2013, to all affected consignees via FedEx beginning on November 23, 2013. Distributors were instructed to notify their customers. Customers were instructed to inspect their inventory for the affected product and quarantine the affected syringes. Complete and return the attached Urgent Field Safety Notice Confirmation Form by fax to 603-358-1017 or by email to LineDraw@smiths-medical.com. Upon receipt of the completed form, a customer service representative will contact them to arrange for exchange of their unused affecte devices for credit or replacement. Customers were instructed to forward the notice to all personnel who need to be aware within their organization and to any organization where the potentially affected devices have been transferred. Customers were instructed to report any issues with the product to Smiths Medical's Global Complaint Department at 1-866-216-8806 or globalcomplaints@smiths-medical.com. For questions regarding this recall call 603-352-3812.
Retiro De Equipo (Recall) de Device Recall RestoreUltra and RestoreSensor
  • Tipo de evento
    Recall
  • ID del evento
    66841
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1524-2014
  • Fecha de inicio del evento
    2014-02-27
  • Fecha de publicación del evento
    2014-04-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-11-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123720
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
  • Causa
    Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. the use of this feature is determined by the physician and set using the clinician programmer. current labeling indicates the use of cycling improves device longevity and recharge interval.
  • Acción
    Medtronic sent a Medical Device Correction letter dated February 2014 to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to do the following: If you have patients with cycling enabled or wish to use cycling, use the updated calculations and graphs available online at professional.medtronic.com/cycling to assess the impact of cycling on device longevity. Medtronic will update the product labeling in the second half of 2014. " Remind your patients to continue to check their battery status. Instructions on how to check battery status can be found in the patient programmer or recharger system manual. " Pain Stimulation Trialing Only: The cycling feature should not be enabled on the External Neurostimulator (ENS) when estimating device longevity because the resulting longevity estimate for non-rechargeable devices may not provide accurate information. Consignees were also instructed to acknowledge receipt of the notice by completing the attached reply form and returning it to Medtronic using the contact details on the reply form. For questions consignees can contact Medtronic Neuromodulation Technical services at 1-800-707-0933 weekdays 7am - 6pm CST. For questions regarding this recall call 800-707-0933.
Alerta De Seguridad para 9 volt alkaline batteries
  • Tipo de evento
    Safety alert
  • País del evento
    Cuba
  • Fuente del evento
    HMC
  • URL de la fuente del evento
    https://www.cecmed.cu/vigilancia/equipos-medicos/alertas
  • Notas / Alertas
    Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Cuba.
  • Notas adicionales en la data
Retiro De Equipo (Recall) de Device Recall FastPack Total PSA Immunoassay
  • Tipo de evento
    Recall
  • ID del evento
    66842
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0547-2014
  • Fecha de inicio del evento
    2013-11-08
  • Fecha de publicación del evento
    2013-12-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123724
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Prostate-specific antigen (psa) for management of prostate cancers - Product Code LTJ
  • Causa
    Qualigen initiated this recall because the fastpack kit may cause lower than expected results due to a manufacturing defect.
  • Acción
    Qualigen, Inc., notified customers of the recall by calling customers via telephone (with a telephone script) on 11/08/2013. The telephone (script) included the reason for recall, product description with codes, instructions and contact information. The customers were instructed to examine your inventory and discontinue use of the kits immediately. Qualigen will send you replacement kits and provide you with a shipping label to return all of the defective kits including any that were partially used. Feel free to contact System Support at 760.579.6900 if you have any questions or require assistance with returning your kits.
Retiro De Equipo (Recall) de Device Recall FastPack Testosterone Immunoassay
  • Tipo de evento
    Recall
  • ID del evento
    66842
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0548-2014
  • Fecha de inicio del evento
    2013-11-08
  • Fecha de publicación del evento
    2013-12-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123725
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Radioimmunoassay, testosterones and dihydrotestosterone - Product Code CDZ
  • Causa
    Qualigen initiated this recall because the fastpack kit may cause lower than expected results due to a manufacturing defect.
  • Acción
    Qualigen, Inc., notified customers of the recall by calling customers via telephone (with a telephone script) on 11/08/2013. The telephone (script) included the reason for recall, product description with codes, instructions and contact information. The customers were instructed to examine your inventory and discontinue use of the kits immediately. Qualigen will send you replacement kits and provide you with a shipping label to return all of the defective kits including any that were partially used. Feel free to contact System Support at 760.579.6900 if you have any questions or require assistance with returning your kits.
Retiro De Equipo (Recall) de Device Recall FastPack Free T4 Immunoassay
  • Tipo de evento
    Recall
  • ID del evento
    66842
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0549-2014
  • Fecha de inicio del evento
    2013-11-08
  • Fecha de publicación del evento
    2013-12-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123729
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Radioimmunoassay, free thyroxine - Product Code CEC
  • Causa
    Qualigen initiated this recall because the fastpack kit may cause lower than expected results due to a manufacturing defect.
  • Acción
    Qualigen, Inc., notified customers of the recall by calling customers via telephone (with a telephone script) on 11/08/2013. The telephone (script) included the reason for recall, product description with codes, instructions and contact information. The customers were instructed to examine your inventory and discontinue use of the kits immediately. Qualigen will send you replacement kits and provide you with a shipping label to return all of the defective kits including any that were partially used. Feel free to contact System Support at 760.579.6900 if you have any questions or require assistance with returning your kits.
Retiro De Equipo (Recall) de Device Recall FastPack Vitamin D Immunoassay
  • Tipo de evento
    Recall
  • ID del evento
    66842
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0550-2014
  • Fecha de inicio del evento
    2013-11-08
  • Fecha de publicación del evento
    2013-12-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123731
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, test, vitamin d - Product Code MRG
  • Causa
    Qualigen initiated this recall because the fastpack kit may cause lower than expected results due to a manufacturing defect.
  • Acción
    Qualigen, Inc., notified customers of the recall by calling customers via telephone (with a telephone script) on 11/08/2013. The telephone (script) included the reason for recall, product description with codes, instructions and contact information. The customers were instructed to examine your inventory and discontinue use of the kits immediately. Qualigen will send you replacement kits and provide you with a shipping label to return all of the defective kits including any that were partially used. Feel free to contact System Support at 760.579.6900 if you have any questions or require assistance with returning your kits.
Retiro De Equipo (Recall) de Device Recall Zimmer Segmental Systems
  • Tipo de evento
    Recall
  • ID del evento
    66846
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0783-2014
  • Fecha de inicio del evento
    2013-12-19
  • Fecha de publicación del evento
    2014-01-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123738
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
  • Causa
    After evaluation of 13 complaints(0.4% rate) for hyper-extension of the zimmer segmental system, zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert.
  • Acción
    Depth of recall " Notifications were sent to customers, surgeons and risk managers, which use the affected product. Distributors were also informed of the notifications sent to surgeons and risk managers. The customers were identified by performing an invoice search and distribution history for the Polyethylene Inserts (00-5850-012-95 and 00-5850-013-95) since product launch. Recall Communication " All distributors were notified via electronic mail. Distributors that have received affected inventory were also notified via courier. Hospital risk managers and surgeons were also notified via courier. On 12/19/13, hospital risk managers and surgeons were provided with a notification identifying the issue and their responsibilities. These responsibilities include ensuring the affected personnel are aware of the contents of the notification. On 12/19/13, Distributors were sent a notification identifying the issue and to provide a copy of the notification sent to surgeons and risk managers. The distributors will also be instructed as needed to assist with identifying a comprehensive list of surgeons. " Communications outside of the United States will occur approximately two weeks after the United States communications. Effectiveness Checks Zimmer will conduct effectiveness checks in the following way: "Surgeons/Hospitals o100% of the FedEx notifications will be accounted for. oSecond and third notification attempts will be made. oFailed delivery attempts following the third attempt will result in the account being deemed as nonresponsive.
Retiro De Equipo (Recall) de Device Recall Gaymar MediTherm
  • Tipo de evento
    Recall
  • ID del evento
    66861
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0933-2014
  • Fecha de inicio del evento
    2013-12-27
  • Fecha de publicación del evento
    2014-02-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-11-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123805
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, thermal regulating - Product Code DWJ
  • Causa
    Stryker medical has identified that on some units of the mta7900, there is a lack of a water temperature display while the unit is in auto mode. while in auto mode, only the patient temperature is displayed along with the set point. the water display will be blank during auto mode. if the user wants to see the water temperature displayed and switches out of auto mode to manual mode, then back to.
  • Acción
    On Dec. 27, 2013, Stryker Medical notified their consignees, identifying the product, reason for the recall and associated risks. Consignees were asked . Locate the units listed attach enclosed warning tags to the units listed. For units that do not have the water temperature displayed, advise staff not to switch to manual mode in order to display the water temperature. Stryker will make arrangements to update the software so that the water temperature will be displayed in both Auto and Manual modes. Fax (269-488-8691) or e-mail (ProductFieldAction@stryker.com ) the enclosed acknowledgment to confirm receipt of this notification. Please forward a copy of this letter to the new users and advise us of their new location and let Stryker know if any units have been discontinued. Questions or concerns, should be addressed to Stryker Customer Service at (1-800-327-0770). Monday-Friday 8 a.m-5 p.m. (ET).
Retiro De Equipo (Recall) de Device Recall Intubation Flexible Fiberscope
  • Tipo de evento
    Recall
  • ID del evento
    66862
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0526-2014
  • Fecha de inicio del evento
    2013-11-13
  • Fecha de publicación del evento
    2013-12-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123806
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Laryngoscope, non-rigid - Product Code CAL
  • Causa
    Karl storz endoscopy america, inc. is recalling the flexible broncho fiberscope or a flexible intubation fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (tpu), which is not listed in sterrad systems claims for interior endoscope lumens.
  • Acción
    The firm, KARL STORZ, sent a "A SAFETY ALERT-ATTENTION NEEDED" letter dated November 8, 2013 to all their customers on November 13, 2013. The letter describes the product, problem and actions to be taken.The letter informs the customers that the endoscopes incorporated a lumen material that is only approved for use as an external surface material and not included in the STERRAD NX and 100NX FDA-cleared claims for use in flexible endoscope lumens. The customers were instructed to follow the recommended processing methods included in the letter. Customers with questions about the letter are instructed to contact the undersigned and the Technical Services at (800) 421-0837, ext 5350.
Retiro De Equipo (Recall) de Device Recall Broncho Flexible Fiberscope
  • Tipo de evento
    Recall
  • ID del evento
    66862
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0527-2014
  • Fecha de inicio del evento
    2013-11-13
  • Fecha de publicación del evento
    2013-12-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123807
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Nasopharyngoscope (flexible or rigid) - Product Code ECQ
  • Causa
    Karl storz endoscopy america, inc. is recalling the flexible broncho fiberscope or a flexible intubation fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (tpu), which is not listed in sterrad systems claims for interior endoscope lumens.
  • Acción
    The firm, KARL STORZ, sent a "A SAFETY ALERT-ATTENTION NEEDED" letter dated November 8, 2013 to all their customers on November 13, 2013. The letter describes the product, problem and actions to be taken.The letter informs the customers that the endoscopes incorporated a lumen material that is only approved for use as an external surface material and not included in the STERRAD NX and 100NX FDA-cleared claims for use in flexible endoscope lumens. The customers were instructed to follow the recommended processing methods included in the letter. Customers with questions about the letter are instructed to contact the undersigned and the Technical Services at (800) 421-0837, ext 5350.
Retiro De Equipo (Recall) de Device Recall SIGMA LCS HIGH PERFORMANCE"
  • Tipo de evento
    Recall
  • ID del evento
    66864
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0412-2014
  • Fecha de inicio del evento
    2013-11-18
  • Fecha de publicación del evento
    2013-11-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123808
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Causa
    Depuy orthopaedics, inc. is issuing a voluntary device correction of the hp m.B.T. keel punch knee instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
  • Acción
    DePuy Orthopaedics sent an Urgent Information - Medical Device Correction letter to all affected customers on November 18, 2013. Immediately after initiation on November 18, the company halted initiation with our US distributors and international affiliates because the surgical technique referenced and images from the surgical technique were not correct. No surgeons received the November 18 surgeon letter. The recall was re-initiated on November 20, 2013. The communication to the surgeons who used the affected devices will be delivered by Distributors either by mail or in person and includes the surgeon letter. The device correction includes awareness, reiteration of surgical techniques and instrument care, and visual check of the device as outlined in the Field Notice and Surgeon letter. The devices are not being removed from the market, but the company is investigating potential design changes to the HP M.B.T. Keel Punch Knee Instrument to reduce the potential for the tabs to fracture. All DePuy United States Distributors and DePuy affiliate contacts for Canada, Latin America and International will be notified via email. The US Distributors will identify surgeons who use the affected instruments on Distributor Response Card #1. The US Distributor will notify surgeons either by mail or in person with the written communication. Once all device correction activities are complete, the US Distributor will complete and return Distributor Card #2 to DePuy Orthopaedics, Inc. The US distributors are the US consignees and are responsible for notifying all new HP M.B.T. Keel Punch Knee Instrument surgeon users of this device correction. All territories are required to ensure the HP M.B.T. Keel Punch Knee Instrument Device Correction is promptly initiated. Customers were asked to review the instructions included, along with the attached documents, which contain important information regarding notification of surgeons affected by this Device Correction. Customers
Retiro De Equipo (Recall) de Device Recall SIGMA LCS HIGH PERFORMANCE"
  • Tipo de evento
    Recall
  • ID del evento
    66864
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0413-2014
  • Fecha de inicio del evento
    2013-11-18
  • Fecha de publicación del evento
    2013-11-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123809
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Causa
    Depuy orthopaedics, inc. is issuing a voluntary device correction of the hp m.B.T. keel punch knee instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
  • Acción
    DePuy Orthopaedics sent an Urgent Information - Medical Device Correction letter to all affected customers on November 18, 2013. Immediately after initiation on November 18, the company halted initiation with our US distributors and international affiliates because the surgical technique referenced and images from the surgical technique were not correct. No surgeons received the November 18 surgeon letter. The recall was re-initiated on November 20, 2013. The communication to the surgeons who used the affected devices will be delivered by Distributors either by mail or in person and includes the surgeon letter. The device correction includes awareness, reiteration of surgical techniques and instrument care, and visual check of the device as outlined in the Field Notice and Surgeon letter. The devices are not being removed from the market, but the company is investigating potential design changes to the HP M.B.T. Keel Punch Knee Instrument to reduce the potential for the tabs to fracture. All DePuy United States Distributors and DePuy affiliate contacts for Canada, Latin America and International will be notified via email. The US Distributors will identify surgeons who use the affected instruments on Distributor Response Card #1. The US Distributor will notify surgeons either by mail or in person with the written communication. Once all device correction activities are complete, the US Distributor will complete and return Distributor Card #2 to DePuy Orthopaedics, Inc. The US distributors are the US consignees and are responsible for notifying all new HP M.B.T. Keel Punch Knee Instrument surgeon users of this device correction. All territories are required to ensure the HP M.B.T. Keel Punch Knee Instrument Device Correction is promptly initiated. Customers were asked to review the instructions included, along with the attached documents, which contain important information regarding notification of surgeons affected by this Device Correction. Customers
Alerta De Seguridad para Automatic External Defibrillator AED 20
  • Tipo de evento
    Safety alert
  • País del evento
    Cuba
  • Fuente del evento
    HMC
  • URL de la fuente del evento
    https://www.cecmed.cu/vigilancia/equipos-medicos/alertas
  • Notas / Alertas
    Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Cuba.
  • Notas adicionales en la data
Retiro De Equipo (Recall) de Device Recall Alaris PC unit model 8000 and 8015
  • Tipo de evento
    Recall
  • ID del evento
    66865
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0534-2014
  • Fecha de inicio del evento
    2013-12-05
  • Fecha de publicación del evento
    2013-12-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-06-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123822
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Pump, infusion - Product Code FRN
  • Causa
    Carefusion is recalling the alaris pc unit (model 8000 and 8015) because the alaris pc unit will produce an audible alarm and the alaris pc unit will display a system error message.
  • Acción
    CareFusion sent an Urgent Medical Device Recall Notification letter dated December 5, 2013, to all affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to contact CareFusion Customer Advocacy at (888) 812-3266, if they experienced a SYSTEM ERROR on the Alaris PC unit. CareFusion will contact all affected customers within 60 days to initiate the scheduling process for the remediation. Customers are instructed to complete and return the enclosed Customer Response Card to expedite the corrective action process. Customers with questions were instructed to contact CareFusion Support Center at 888-562-6018, or for Technical Support call 888-812-3229.
Retiro De Equipo (Recall) de Device Recall Patient Side Manipulator
  • Tipo de evento
    Recall
  • ID del evento
    66866
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0436-2014
  • Fecha de inicio del evento
    2013-11-11
  • Fecha de publicación del evento
    2013-12-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123823
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System,surgical,computer controlled instrument - Product Code NAY
  • Causa
    Reports of friction within certain instrument arms can interrupt smooth instrument motion. this can be felt by the surgeon as resistance in the movement of the master.In this situation, the instrument can stall momentarily and then suddenly catch-up to the master position if the surgeon pushes through the resistance.
  • Acción
    The firm, Intuitive Surgical, sent an "Urgent Medical Device Recall" letter dated November 11, 2013 all affected customers via traceable mail. The letter described the product, problem and actions to be taken. The customers were instructed to take the following actions: 1. Ensure all appropriate personnel are fully informed of this Notification. Forward this letter to all Surgeons and OR staff who perform da Vinci surgical procedures, Risk Manager, OR Director, Purchasing, and Biomedical Engineering staff. 2. Complete the attached Acknowledgement Form and return it to Intuitive Surgical via Fax to: Intuitive Surgical, Inc., ATTN: REGULATORY AFFAIRS U.S. +1 (408) 716-3040, or Scan and Email: isi.compliance@intusurg.com. 3. An Intuitive Surgical Representative will contact your site to schedule the inspection of the instrument arms on your system(s) as indicated above. Please work with the Intuitive Surgical Representative to schedule this activity. 4. Please inform appropriate personnel when the correction has been completed. 5. Please retain a copy of this letter and the Acknowledgement Form for your files. If you need further information or support concerning this medical device correction, then please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below. ¿ North and South America: 800-876-1310 Option 3 (6 am to 5pm PST) ¿ Japan: 0120-56-5635 or 03-5575-1362 (9am to 6pm JST) ¿ South Korea: 02-3271-3200 (9am to 6pm KSTJ) ¿ Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET).
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