• Acerca de la base de datos
  • ¿Cómo usar la IMDD?
  • Descargar la data
  • Preguntas frecuentes
  • Créditos
Vista de la lista Vista de las tarjetas
  • Dispositivo 25
  • Fabricante 5
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de Device Recall 20Pole Eco Cable
  • Tipo de evento
    Recall
  • ID del evento
    64579
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1023-2013
  • Fecha de inicio del evento
    2013-03-05
  • Fecha de publicación del evento
    2013-03-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-10-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116525
  • 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
    Computer, diagnostic, programmable - Product Code DQK
  • Causa
    Biosense is recalling the 20-pole eco cable because it was incorrectly calibrated. when a catheter is connected to an affected to an affected 20-pole eco cable, the catheter will not be recognized by the impacted 54 cable serial numbers within the field.
  • Acción
    Biosense Webster sent an Urgent Field Notice Medical Device Letter dated March 5, 2013 to all affected customers. The letter identified the affected product, problem and the actions to be taken. Customers with questions are instructed to contact Biosense Webster sales representatives or call (866) 473-7823, Mon-Friday from 7amto 8pm EST.
Retiro De Equipo (Recall) de Device Recall Molift Smart 150
  • Tipo de evento
    Recall
  • ID del evento
    64512
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1343-2013
  • Fecha de inicio del evento
    2013-02-15
  • Fecha de publicación del evento
    2013-05-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-07-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116530
  • 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
    Lift, patient, non-ac-powered - Product Code FSA
  • Causa
    The leg spreading mechanism will fail to hoist and collapse if assemble incorrectly by the user.
  • Acción
    Molift Group AS issued a Field Safety Notice letter to all affected customers. The letter identified the affected products, problem and actions to be taken to the Smart hoists that are already in use. Customers were instructed to make sure that all affected customers receive this information and encorage to increase attention until the affected product has been upgraded. For questions contact your local Molift representative or Customer Service at: groupsales@molift.com.
Retiro De Equipo (Recall) de Device Recall Anspach Custom Autolube Food Guard
  • Tipo de evento
    Recall
  • ID del evento
    64247
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1919-2014
  • Fecha de inicio del evento
    2012-11-28
  • Fecha de publicación del evento
    2014-06-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116534
  • 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 anspach effort, inc. in palm beach gardens, fl is recalling their anspach custom devices. the units were not manufactured consistently with quality system requirements.
  • Acción
    The Anspach Effort, Inc. sent an Urgent Medical Device Recall letter dated December 21, 2012 to all affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to remove and return the affected products and complete the attached reply form and return to The Anspach Effort Inc. For questions contact Anspach Product Support at (800) 327-6887. For questions regarding this recall call 561-494-3706.
Retiro De Equipo (Recall) de Device Recall TotalCare SpO2RT 2 bed
  • Tipo de evento
    Recall
  • ID del evento
    64580
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0949-2013
  • Fecha de inicio del evento
    2013-02-26
  • Fecha de publicación del evento
    2013-03-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116540
  • 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
    Bed, flotation therapy, powered - Product Code IOQ
  • Causa
    In certain situations a software problem with the totalcare spo2rt¿ 2 bed may occur that can lead to inadvertent loss of sufficient surface cushion pressure to adequately support the patient. this may increase the likelihood of skin irritation for patients at higher risk of developing pressure-related skin conditions. a correction to the software program is currently being developed and tested,.
  • Acción
    Hill-Rom sent an Urgent Field Safey Notice letter dated February 26, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter advised customers to follow steps provided until the updated software is available. Customers were requested to forward a copy of this letter to any other facility personnel you deem appropriate. Questions should be directed to Hill-Rom Technical Support at 800-445-3720
Retiro De Equipo (Recall) de Device Recall Orthopedic Alliance Spine System (alias "Blue & Gold")
  • Tipo de evento
    Recall
  • ID del evento
    64584
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1156-2013
  • Fecha de inicio del evento
    2013-03-07
  • Fecha de publicación del evento
    2013-04-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116550
  • 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
    Orthosis, spinal pedicle fixation - Product Code MNI
  • Causa
    Orthopedic alliance is recalling blue & gold implants and instruments because the blue & gold system is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. these inadequacies might result in product peformance failures that could cause patient harm due to implant breakage, loosening, or inadequate sterilization.
  • Acción
    A recall letter dated March 7, 2013 was sent to one customer who purchased the Blue & Gold Implants and instruments. The letter informed the customer that the Blue & Gold system is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies might result in product performance failures that could cause patient harm due to implant breakage, loosening, or inadequate sterilization. Customer is informed of the actions to be taken. Customer is instructed to complete the customer response form and return it by FAX to (858) 764-9739.
Retiro De Equipo (Recall) de Device Recall Inspira AIR Balloon Dilation system
  • Tipo de evento
    Recall
  • ID del evento
    64625
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1865-2013
  • Fecha de inicio del evento
    2013-01-11
  • Fecha de publicación del evento
    2013-08-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-10-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116656
  • 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
    Bronchoscope accessory - Product Code KTI
  • Causa
    Labeling correction for all sizes of the inspira air balloon dilation system to include additional language and warnings as well as to clarify some instructional steps.
  • Acción
    Urgent Medical Device Labeling correction letters will be sent to all consignees through a delivery system that can track delivery. After CDRH review and corrections, Acclarent began issuing customer notification on August 7, 2013
Retiro De Equipo (Recall) de Device Recall PEDICLE SCREW SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    64586
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1409-2013
  • Fecha de inicio del evento
    2013-02-20
  • Fecha de publicación del evento
    2013-05-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116552
  • 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
    Orthosis, spinal pedicle fixation - Product Code MNI
  • Causa
    The recall of the loaner bin and sterilization trays for implants and instruments was initiated by spinal solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
  • Acción
    Spinal Solutions sent a recall letter dated March 8, 2013 to all customers who purchased loaner bins and sterilization trays for implants and instruments from Spinal Solutions. The letter identified the affected product, problem identified and actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
Retiro De Equipo (Recall) de Device Recall Sepp
  • Tipo de evento
    Recall
  • ID del evento
    64585
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1001-2013
  • Fecha de inicio del evento
    2013-03-04
  • Fecha de publicación del evento
    2013-03-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116553
  • 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
    Skin prep tray (kit) - Product Code OJU
  • Causa
    An internal review of carefusion's labeling for preoperative skin prep product codes was recently conducted. the labeling of the product codes identified above state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. the antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized.
  • Acción
    CareFusion sent an Urgent Recall Notice dated March 4, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately check inventory, quarantine and return the affected product for replacement. For questions call (913) 345-3504.
Retiro De Equipo (Recall) de Device Recall Femoral component
  • Tipo de evento
    Recall
  • ID del evento
    64588
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1378-2013
  • Fecha de inicio del evento
    2013-02-20
  • Fecha de publicación del evento
    2013-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116554
  • 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
    The recall of the loaner bin and sterilization trays for implants and instruments was initiated by orthopedic alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
  • Acción
    A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
Retiro De Equipo (Recall) de Device Recall Teleflex Medical Berman Angiographic Balloon Catheter...
  • Tipo de evento
    Recall
  • ID del evento
    64593
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1057-2013
  • Fecha de inicio del evento
    2013-03-04
  • Fecha de publicación del evento
    2013-04-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-12-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116571
  • 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
    Catheter, flow directed - Product Code DYG
  • Causa
    The product specifications sheet, part of the instructions for use (ifu), for the specified product numbers, reference renografin-76 contrast medium (viscosity of 8.4 centipoise), which is no longer available. firm is in the process of updating the labeling for these products. in the meantime, when choosing an alternative contrast medium, health care providers are instructed to select a contrast.
  • Acción
    Arrow sent an Urgent Medical Device Customer Notification letter dated March 4, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Arrow is in the process of updating the labeling; in the meantime they wanted to instruct all customers to select a contrast medium with a viscosity of 8.4 centipoise or lower for use with the pressure and flow settings specified in the current IFU. In addition, they are placing an insert card in kits for the specified product codes alerting them that Renografin-76 is no longer available and to select a contract medium with a viscosity of 8/4 centipose or lower for use with the pressure and flow setting specified in the current IFU. Arrow remains committed to providing high quality, safe and effective products. If you require additional information or clarification regarding this matter, please contact your Sales Representative or Arrow's Customer Service Department at (866) 396-2111.
Retiro De Equipo (Recall) de Device Recall Dimension Vista(R) System Vista Drug 4 Calibrator
  • Tipo de evento
    Recall
  • ID del evento
    64596
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1151-2013
  • Fecha de inicio del evento
    2013-02-21
  • Fecha de publicación del evento
    2013-04-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-01-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116574
  • 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
    Enzyme immunoassay, digoxin - Product Code KXT
  • Causa
    Siemens has confirmed complaints of low qc and patient recovery with the dimension vista(r) loci(r) digoxin(digxn) flex(r) reagent cartridge when calibrating digxn with either drug 4 cal (kc460) lot 2kd052 or drug 4 cal (kc460a) lot 2kd053. internal testing has shown an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/ml.
  • Acción
    The firm initiated their recall of this product by sending an Urgent Medical Device Recall letter dated February 2013 to all Dimension Vista Drug 4 Calibrator customers who received the affected lots. The letter notified them of the issue, the potential risk to health, and actions to be taken by customers.
Retiro De Equipo (Recall) de Device Recall Morphine Strip (300
  • Tipo de evento
    Recall
  • ID del evento
    67665
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1384-2014
  • Fecha de inicio del evento
    2014-03-04
  • Fecha de publicación del evento
    2014-04-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126020
  • 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
  • Causa
    Products shipped to us locations that do not have approved applications for pma , ide or 510(k) clearance.
  • Acción
    Urgent Device Recall notification letters were sent to all US consignees on March 4, 2014 by e-mail and US mail as well as a phone call. The letter identified the products and actions to be taken by the customers.
Retiro De Equipo (Recall) de Device Recall STERRAD 200 Carriage
  • Tipo de evento
    Recall
  • ID del evento
    64609
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0998-2013
  • Fecha de inicio del evento
    2012-03-13
  • Fecha de publicación del evento
    2013-03-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116598
  • 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
    Sterilizer, chemical - Product Code MLR
  • Causa
    Advanced sterilization products (asp) is recalling the sterrad 200 system carriage because it can potentially become dislodged when an excessive load is applied.
  • Acción
    Advanced Sterilization Products (ASP) sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated March 13, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter informed the customers that ASP recently determined that the push bar located on the STERRAD 200 System Carriage can potentially become dislodged when an excessive load is applied. Customers with questions are instructed to contact Stericycle at (877) 931-0642.
Retiro De Equipo (Recall) de Device Recall Siemens ADVIA Centaur Vitamin D Assay (100 tests)
  • Tipo de evento
    Recall
  • ID del evento
    64610
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1119-2013
  • Fecha de inicio del evento
    2013-03-13
  • Fecha de publicación del evento
    2013-04-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116599
  • 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
    Negative bias in patient samples for vitamin d.
  • Acción
    Siemens Healthcare issued Urgent Medical Device Recall was sent to all affected Siemens Healthcare Diagnostics customers in the United States on March 13th, 2013. This notice informs the customer of the recall and the actions that need to be taken. The Urgent Medical Device Recall instructs customers to discontinue the use of ADVIA Centaur VitD Assay Kit Lots (REF 10491994 and 10631021) and ADVIA Centaur Systems VitD Cal (REF 10493589 and 10630911) released prior to the recalibration of the assay and request replacement lots. This notice also directs customers to review the contents of the recall notice with their laboratory or medical director. A confirmation fax-back form is included to ensure that all customers in the United States have been notified and have complied with the mandatory action.
Retiro De Equipo (Recall) de Device Recall Siemens ADVIA Centaur Vitamin D Assay (500 tests)
  • Tipo de evento
    Recall
  • ID del evento
    64610
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1120-2013
  • Fecha de inicio del evento
    2013-03-13
  • Fecha de publicación del evento
    2013-04-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116600
  • 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
    Negative bias in patient samples for vitamin d.
  • Acción
    Siemens Healthcare issued Urgent Medical Device Recall was sent to all affected Siemens Healthcare Diagnostics customers in the United States on March 13th, 2013. This notice informs the customer of the recall and the actions that need to be taken. The Urgent Medical Device Recall instructs customers to discontinue the use of ADVIA Centaur VitD Assay Kit Lots (REF 10491994 and 10631021) and ADVIA Centaur Systems VitD Cal (REF 10493589 and 10630911) released prior to the recalibration of the assay and request replacement lots. This notice also directs customers to review the contents of the recall notice with their laboratory or medical director. A confirmation fax-back form is included to ensure that all customers in the United States have been notified and have complied with the mandatory action.
Retiro De Equipo (Recall) de Device Recall Siemens ADVIA Centaur Vitamin D Calibrator 2pack
  • Tipo de evento
    Recall
  • ID del evento
    64610
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1121-2013
  • Fecha de inicio del evento
    2013-03-13
  • Fecha de publicación del evento
    2013-04-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116601
  • 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
    Calibrator, primary - Product Code JIS
  • Causa
    Negative bias in patient samples for vitamin d.
  • Acción
    Siemens Healthcare issued Urgent Medical Device Recall was sent to all affected Siemens Healthcare Diagnostics customers in the United States on March 13th, 2013. This notice informs the customer of the recall and the actions that need to be taken. The Urgent Medical Device Recall instructs customers to discontinue the use of ADVIA Centaur VitD Assay Kit Lots (REF 10491994 and 10631021) and ADVIA Centaur Systems VitD Cal (REF 10493589 and 10630911) released prior to the recalibration of the assay and request replacement lots. This notice also directs customers to review the contents of the recall notice with their laboratory or medical director. A confirmation fax-back form is included to ensure that all customers in the United States have been notified and have complied with the mandatory action.
Retiro De Equipo (Recall) de Device Recall Siemens ADVIA Centaur Vitamin D Calibrator 6pack
  • Tipo de evento
    Recall
  • ID del evento
    64610
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1122-2013
  • Fecha de inicio del evento
    2013-03-13
  • Fecha de publicación del evento
    2013-04-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116602
  • 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
    Calibrator, primary - Product Code JIS
  • Causa
    Negative bias in patient samples for vitamin d.
  • Acción
    Siemens Healthcare issued Urgent Medical Device Recall was sent to all affected Siemens Healthcare Diagnostics customers in the United States on March 13th, 2013. This notice informs the customer of the recall and the actions that need to be taken. The Urgent Medical Device Recall instructs customers to discontinue the use of ADVIA Centaur VitD Assay Kit Lots (REF 10491994 and 10631021) and ADVIA Centaur Systems VitD Cal (REF 10493589 and 10630911) released prior to the recalibration of the assay and request replacement lots. This notice also directs customers to review the contents of the recall notice with their laboratory or medical director. A confirmation fax-back form is included to ensure that all customers in the United States have been notified and have complied with the mandatory action.
Retiro De Equipo (Recall) de Device Recall Archer Super Stiff Guidewire
  • Tipo de evento
    Recall
  • ID del evento
    64620
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1017-2013
  • Fecha de inicio del evento
    2013-03-13
  • Fecha de publicación del evento
    2013-03-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-11-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116638
  • 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
    Wire, guide, catheter - Product Code DQX
  • Causa
    Medtronic has identified an issue with a specific lot of the archer 0.035 inch (0.89mm) super stiff guidewire, model arcsj200w, where the ptfe (teflon) coating has the potential to separate from the wire during in-vivo use.
  • Acción
    Medtronic sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Medtronic requested any unused guidewires from the lot number to be quarantined, and returned by contacting the customer service phone number at 1-888-283-7868. A Customer Confirmation Certificate was requested to be faxed back to Medtronic at 651-367-0612.
Retiro De Equipo (Recall) de Device Recall SL3 SOFTTISSUE Laser
  • Tipo de evento
    Recall
  • ID del evento
    64621
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1186-2013
  • Fecha de inicio del evento
    2011-07-21
  • Fecha de publicación del evento
    2013-04-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-04-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116642
  • 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
    Powered laser surgical instrument - Product Code GEX
  • Causa
    The firm is initiating this recall of the sl3 soft tissue laser equipped with a fiber optic unifiber system which contains a fragile glass filament because the fiber broke near the hand piece.
  • Acción
    DISCUS Dental, sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated July 21, 2011. The letter described the product, problem and action to be taken. Customers were instructed tocontact Discus Dental at 1-888-427-9279 for a no-cost replacement. For questions regarding this recall call 310-845-8200.
Retiro De Equipo (Recall) de Device Recall Archer 0.035 inch (0.89mm) Super Stiff Guidewire
  • Tipo de evento
    Recall
  • ID del evento
    64623
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1019-2013
  • Fecha de inicio del evento
    2013-03-13
  • Fecha de publicación del evento
    2013-03-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116647
  • 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
    Wire, guide, catheter - Product Code DQX
  • Causa
    Medtronic has identified an issue involving specific lot numbers of the medtronic archer 0.035 inch (0.89mm) super stiff guidewire, models arcsj200w, arcsj260w, and arcdj260w, where a change in the manufacturing process has been identified as the cause for potential kinking and breaking at the proximal weld end of the outer spring coil during in-vivo use.
  • Acción
    Medtronic sent an Urgent Medical Device Recall letter dated March 2013 to all affected customers. The letter identifies the affected product, problem and actions to be taken. Customers were instructed to immediately quarantine all affected products and returned to Medtronic. Customers were requested to complete the attached Customer Confirmation Certificate and fax it to Medtronic to the attention of Customer Focused Quality. For question contact your local Medtronic representative or Medtronic Customer Service at 1-888-283-7868.
Retiro De Equipo (Recall) de Device Recall OneTouch Verio IQ Blood Glucose Monitoring System
  • Tipo de evento
    Recall
  • ID del evento
    64624
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1074-2013
  • Fecha de inicio del evento
    2013-03-11
  • Fecha de publicación del evento
    2013-04-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116649
  • 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, blood glucose, over the counter - Product Code NBW
  • Causa
    The verio iq meter will shut off and revert to set up mode at glucose values above 1023 instead of displaying extreme high glucose.
  • Acción
    Lifescan sent an Urgent Medical Device Voluntary Recall letter dated March 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to identify and hold all affected product in inventory and discontinue distributing. The letter states that a Lifescan sales representative will contact customers to arrange for pick up and replacement.
Retiro De Equipo (Recall) de Device Recall Inspira AIR Balloon Dilation system
  • Tipo de evento
    Recall
  • ID del evento
    64625
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1860-2013
  • Fecha de inicio del evento
    2013-01-11
  • Fecha de publicación del evento
    2013-08-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-10-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116651
  • 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
    Bronchoscope accessory - Product Code KTI
  • Causa
    Labeling correction for all sizes of the inspira air balloon dilation system to include additional language and warnings as well as to clarify some instructional steps.
  • Acción
    Urgent Medical Device Labeling correction letters will be sent to all consignees through a delivery system that can track delivery. After CDRH review and corrections, Acclarent began issuing customer notification on August 7, 2013
Retiro De Equipo (Recall) de Device Recall Inspira AIR Balloon Dilation system
  • Tipo de evento
    Recall
  • ID del evento
    64625
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1861-2013
  • Fecha de inicio del evento
    2013-01-11
  • Fecha de publicación del evento
    2013-08-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-10-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116652
  • 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
    Bronchoscope accessory - Product Code KTI
  • Causa
    Labeling correction for all sizes of the inspira air balloon dilation system to include additional language and warnings as well as to clarify some instructional steps.
  • Acción
    Urgent Medical Device Labeling correction letters will be sent to all consignees through a delivery system that can track delivery. After CDRH review and corrections, Acclarent began issuing customer notification on August 7, 2013
Retiro De Equipo (Recall) de Device Recall NIM TriVantage EMG Endotracheal Tube
  • Tipo de evento
    Recall
  • ID del evento
    64631
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1420-2013
  • Fecha de inicio del evento
    2013-03-04
  • Fecha de publicación del evento
    2013-06-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-01-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116684
  • 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, nerve - Product Code ETN
  • Causa
    In march 2013, medtronic issued a recall of the nim trivantage emg endotracheal tube due to cuff leakage in the intraoperative cuff deflation which then requires re-inflation or replacement of the deflated tube in order to ensure the continued ventilation of the patient.
  • Acción
    The firm, Medtronic Xomed, Inc. sent an "URGENT Product Recall Notification" letter dated March 14, 2013, to its U.S. and International customers. The letter described the product, problem and actions to be taken. The customers were instructed to return any affected devices still in their possession per the following procedure: 1. Check inventories for the affected products listed on the enclosed checklist. 2. Fill-in the "quantity on-hand" column on the checklist. 3. Fax checklist to Medtronic ENT at 1-904-296-2386. 4. If you have any of the subject product, contact Medtronic ENT Customer Service at 1-800-874-5797 to arrange for returns and replacement or credit. 5.When returning products, clearly mark the outside of the container Returned Goods Authorization (RGA) number. If you have any questions regarding the subject action or the content of the letter, contact Gabriela Anchondo at 904-279-7550.
Retiro De Equipo (Recall) de Device Recall Keystone PrimaConnex Tapered Implant TC
  • Tipo de evento
    Recall
  • ID del evento
    64633
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0973-2013
  • Fecha de inicio del evento
    2013-03-11
  • Fecha de publicación del evento
    2013-03-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116685
  • 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
    Accessories, implant, dental, endosseous - Product Code NDP
  • Causa
    Mislabeled: cover screw that was in the package was a wd cover screw and not a sd cover screw as labeled.
  • Acción
    Keystone Dental initially called customers on 3/11/13 and forms were completed to document these calls. In addition, a letter sent via Federal Express/or hand delivered to all distributors and customers. Product requested to be returned.
  • 1
  • 2
  • 3
  • …
  • Next ›
  • Last »

Acerca de la base de datos

Explore más de 120,000 registros de retiros, alertas y notificaciones de seguridad de dispositivos médicos y sus conexiones con los fabricantes.

  • Preguntas frecuentes
  • Acerca de la base de datos
  • Contáctenos
  • Créditos

Historias en su correo

¿Trabaja en la industria médica? ¿O tiene experiencia con algún dispositivo médico? Nuestra reportería no ha terminado. Queremos oír de usted.

¡Cuéntanos tu historia!

Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.