• 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 960
  • Fabricante 297
  • Evento 124969
  • Implante 79
Retiro De Equipo (Recall) de ARCHITECT STAT TroponinI Reagent Kit
  • Tipo de evento
    Recall
  • ID del evento
    61630
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1509-2012
  • Fecha de inicio del evento
    2012-04-11
  • Fecha de publicación del evento
    2012-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108593
  • 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
    Immunoassay method, troponin subunit - Product Code MMI
  • Causa
    The lot of troponin-i is demonstrating a shift in expected results in some cases, and varies from kit to kit. a concentration change of up to +/-55% could occur when switching kits without recalibrating.
  • Acción
    The firm, Abbott Laboratories, sent a "Product Recall Immediate Action Required"letter dated April 11, 2012 to all Troponin-I customers who received the affected reagent lot internationally. The customers were directed to determine if they are currently using and/or have inventory of lot 74264UN11; to discontinue use and destroy any remaining inventory of the lot; to follow their facility's policies and procedures for communicating with the heath care providers they serve; to forward a copy of the letter to any laboratory to whom they may have forwarded the reagent; to retain a copy of the letter for their records and to complete and return the Customer Reply Form (sent to Abbott international affiliates via e-mail on 4/11/2012) via fax to: 1-800-777-0051 or e-mail: QAGCO@abbott.com. Any questions were directed to their local Customer Service representative or call the field action coordinator at 847-938-1923 or email: albert.chianello@abbott.com.
Retiro De Equipo (Recall) de EPIFLO
  • Tipo de evento
    Recall
  • ID del evento
    61635
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1477-2012
  • Fecha de inicio del evento
    2012-04-16
  • Fecha de publicación del evento
    2012-04-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108599
  • 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
    Chamber, oxygen, topical, extremity - Product Code KPJ
  • Causa
    Ogenix initiated a voluntary recall for the epiflo-15 devices due to a mislabeling of the expiry date for this lot. instead of march 2013, this lot carried may 2013 as the expiry date.
  • Acción
    Ogenix sent a letter dated March 16, 2012 to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Customers were instructed to confirm the status of the devices and ship product with the recalled lot back to Ogenix and complete the form provided with the letter.
Retiro De Equipo (Recall) de Aestiva/5 7900 SmartVent
  • Tipo de evento
    Recall
  • ID del evento
    61639
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1787-2012
  • Fecha de inicio del evento
    2012-04-10
  • Fecha de publicación del evento
    2012-06-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108604
  • 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
    Ventilator, continuous, facility use - Product Code CBK
  • Causa
    Ge healthcare has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of your aestiva 7900 anesthesia device. this potential for two (2) vaporizers delivering agent at the same time. this could manifest as over delivery of a single agent if both vaporizers contain the same agent or as delivery of more than one agent. this m.
  • Acción
    GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 10, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact GE Healthcare Customer or Technical Support at 800-345-2700 for questions regarding this notification.
Retiro De Equipo (Recall) de CAPIOX RX Hollow Fiber Oxygenators
  • Tipo de evento
    Recall
  • ID del evento
    61644
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1523-2012
  • Fecha de inicio del evento
    2012-04-12
  • Fecha de publicación del evento
    2012-05-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108615
  • 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
    Oxygenator, cardiopulmonary bypass - Product Code DTZ
  • Causa
    Loose connections (i.E., connections between pvc circuit tubing and oxygenator ports) may result in leaks and patient blood loss.
  • Acción
    Terumo Cardiovascular Systems issued an Urgent Medical Device Recall notification on 4/12/12 to all user facilities/consignees who have received affected devices. The letter identified the affected product, stated the reason for the recall, the potential hazard involved, and the correction. Users are to review the letter, ensure that all users are made aware of the issue, discontinue use of the affected product, and return it to Terumo CVS. In addition, users are to return the response form to the manufacturer. Affected units will be replaced with new units. Contact Terumo CVS Customer Service @ 1-800-521-2818 or tcvs.recall@teruomedical.com
Retiro De Equipo (Recall) de CAPIOX FX Hollow Fiber Oxygenators
  • Tipo de evento
    Recall
  • ID del evento
    61644
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1524-2012
  • Fecha de inicio del evento
    2012-04-12
  • Fecha de publicación del evento
    2012-05-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108616
  • 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
    Oxygenator, cardiopulmonary bypass - Product Code DTZ
  • Causa
    Loose connections (i.E., connections between pvc circuit tubing and oxygenator ports) may result in leaks and patient blood loss.
  • Acción
    Terumo Cardiovascular Systems issued an Urgent Medical Device Recall notification on 4/12/12 to all user facilities/consignees who have received affected devices. The letter identified the affected product, stated the reason for the recall, the potential hazard involved, and the correction. Users are to review the letter, ensure that all users are made aware of the issue, discontinue use of the affected product, and return it to Terumo CVS. In addition, users are to return the response form to the manufacturer. Affected units will be replaced with new units. Contact Terumo CVS Customer Service @ 1-800-521-2818 or tcvs.recall@teruomedical.com
Retiro De Equipo (Recall) de Churchill Medical Systems 22Ga Winged Infusion Set
  • Tipo de evento
    Recall
  • ID del evento
    61653
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1480-2012
  • Fecha de inicio del evento
    2012-04-16
  • Fecha de publicación del evento
    2012-05-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108644
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • Causa
    Mislabeled: mbs-2210 code on case label -22ga winged infusion set, ; however, the product label states 20ga mbs-2010 code listed on device label.
  • Acción
    The firm, VYGON, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 16, 2012 to its customers via overnight, courier service. The letter described the product, problem and actions to be taken. The customers were instructed to check their stock for the products included within the scope of the recall; count and document their affected inventory; contact Vygon's Customer Service Department at 1-800-473-5414 for return merchandise authorization number; return the affected product; complete and immediately return the Acknowledgement and Inventory Return Form via fax to 215-672-6740 and send the original form with their shipment . Distributors were instructed to communicate this recall to their customers and provide them with the Acknowledgement and Inventory Return Form for completion and return. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@yygonus.com.
Retiro De Equipo (Recall) de QuickSite, QuickSite XL
  • Tipo de evento
    Recall
  • ID del evento
    61656
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1482-2012
  • Fecha de inicio del evento
    2012-04-03
  • Fecha de publicación del evento
    2012-05-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108650
  • 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
    Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) - Product Code NIK
  • Causa
    Visual observations of externalized conductors due to abrasion of the silicone insulation in the distal portion of these quicksite and quickflex leads.
  • Acción
    A recall communication was initiated on 4/3/12 with St. Jude Medical forwarding a Medical Device Advisory to all doctors who have received the St. Jude QuickSite and QuickFlex Left Ventricular CRT leads models 1056T, 1058T, 1156T, and 1158T. The letter provides the doctors with the problems identified and actions to be taken. Doctors with any questions or concerns are instructed to contact their local St. Jude Medical representative or their Technical Services Department at (800) 722-3774. A Physician Device Advisory Notice for the QuickSite and QuickFlex Left Ventricular CRT Leads was issued on 4/3/12 to physicians who have received the recalled products. The notice provides the physicians with the problem identified and actions to be taken. Physicians are instructed to return any packaged product in hospital inventory to SJM Sales Representatives. For implanted product, due to the nature of the issue, externalized conductors may be observed with no electrical or performance anomalies. Therefore, prophylactic explant is not recommended. It is recommended that physicians continue to monitor their patients' implanted system at regularly scheduled intervals. A Medical Advisory and Inventory Management Information letter was sent on 4/3/12 to hospital administrators to notify them of the problems identified and the actions to be taken.
Retiro De Equipo (Recall) de QuickFlex, QuickFlex XL
  • Tipo de evento
    Recall
  • ID del evento
    61656
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1483-2012
  • Fecha de inicio del evento
    2012-04-03
  • Fecha de publicación del evento
    2012-05-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108651
  • 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
    Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) - Product Code NIK
  • Causa
    Visual observations of externalized conductors due to abrasion of the silicone insulation in the distal portion of these quicksite and quickflex leads.
  • Acción
    A recall communication was initiated on 4/3/12 with St. Jude Medical forwarding a Medical Device Advisory to all doctors who have received the St. Jude QuickSite and QuickFlex Left Ventricular CRT leads models 1056T, 1058T, 1156T, and 1158T. The letter provides the doctors with the problems identified and actions to be taken. Doctors with any questions or concerns are instructed to contact their local St. Jude Medical representative or their Technical Services Department at (800) 722-3774. A Physician Device Advisory Notice for the QuickSite and QuickFlex Left Ventricular CRT Leads was issued on 4/3/12 to physicians who have received the recalled products. The notice provides the physicians with the problem identified and actions to be taken. Physicians are instructed to return any packaged product in hospital inventory to SJM Sales Representatives. For implanted product, due to the nature of the issue, externalized conductors may be observed with no electrical or performance anomalies. Therefore, prophylactic explant is not recommended. It is recommended that physicians continue to monitor their patients' implanted system at regularly scheduled intervals. A Medical Advisory and Inventory Management Information letter was sent on 4/3/12 to hospital administrators to notify them of the problems identified and the actions to be taken.
Retiro De Equipo (Recall) de 8" x 4" 16ply XRay Gauze
  • Tipo de evento
    Recall
  • ID del evento
    61681
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1517-2012
  • Fecha de inicio del evento
    2012-04-09
  • Fecha de publicación del evento
    2012-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-12-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108704
  • 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
    Gauze/sponge, internal, x-ray detectable - Product Code GDY
  • Causa
    The lots of x-ray gauze are contaminated with foreign material, including remnants of cotton seeds and lint.
  • Acción
    International Medsurg Connection notified their direct accounts via telephone, e-mail and/or fax on April 9, 2012, informing them of the foreign material contamination of the gauze, and requesting them to quarantine all affected lots in inventory, cease distribution of the affected product, and notify any customers at the retail level to remove and discard these products. Any questions were directed to (847) 619-9926.
Retiro De Equipo (Recall) de Stratus(R) CS Acute care(TM) NT
  • Tipo de evento
    Recall
  • ID del evento
    61661
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1516-2012
  • Fecha de inicio del evento
    2012-04-05
  • Fecha de publicación del evento
    2012-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108660
  • 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
    Test, natriuretic peptide - Product Code NBC
  • Causa
    Firm has confirmed a low frequency of calibration failures due to slope errors that are not resolved with routine maintenance with the specific scs pro-bnp lots listed. this issue only causes the slope error failures but does not affect patient results when the calibration is within specifications.
  • Acción
    The firm, SIEMENS, sent a "Urgent Field Safety Notice" dated March, 2012 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to discontinue use of the lots once revised expiration date occurs; contact their local Siemens Customers Service Center at 888-588-3916 for replacement; complete and return the FIELD CORRECTION EFFECTIVENESS CHECK form via fax to the TECHNICAL SOLUTIONS CENTER at (302) 631-8467 as soon as possible, and forward this notification to anyone to whom they may have distributed this product. The remaining inventory at the firm was destroyed. If you have any technical questions regarding this information, please contact the Siemens Technical Solutions Center at 800-405-6473.
Retiro De Equipo (Recall) de Tracheostomy tubes
  • Tipo de evento
    Recall
  • ID del evento
    61663
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1628-2012
  • Fecha de inicio del evento
    2012-04-18
  • Fecha de publicación del evento
    2012-05-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108664
  • 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
    Tube, tracheostomy (w/wo connector) - Product Code BTO
  • Causa
    A defect in 3 tracheostomy tubes. the defect observed was a separation in the bond between the proximal junction of the neck flange and the cannula.
  • Acción
    Arcadia notified the 3 consignees with a MEDICAL DEVICE VOLUNTARY RECALL notification dated 4/18/12. The notification identified the affected product, along with the reason for the recall. Consignees were instructed to cease distribution/use of any unopened product that they have remaining and return to firm following the steps provided. Arcadia will replace the product at no charge to the customer. Consignees were to confirm receipt of the recall notification by emailing Trena Depel, trena@arcadiamedical.com. Phone: 925-918-0595 Fax: (415) 762-5489
Retiro De Equipo (Recall) de Microsoft Amalga UIS 2009
  • Tipo de evento
    Recall
  • ID del evento
    61673
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1702-2012
  • Fecha de inicio del evento
    2012-04-12
  • Fecha de publicación del evento
    2012-06-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-12-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108695
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Causa
    Microsoft amalga uis 2009 has an issue with the display of lab results in the lab details window of the lab result viewer. the lab details view does not freeze/pin the row header when the user scroll horizontally.
  • Acción
    Microsoft Corporation Health Solutions Group sent an "URGENT FIELD SAFETY NOTICE" dated April 12, 2012 to all affected customers via e-mail. The letter identifies the product, problem, and actions to be taken by the customers. The firm plans to revise its labeling for Amalga to clarify that the row headers will not be visible as the user scrolls horizontally. Customers were asked to complete and return to the firm a response form via fax at 425-706-7329 or e-mail to vlpigin@microsoft.com.
Retiro De Equipo (Recall) de DISPOSASHIELD
  • Tipo de evento
    Recall
  • ID del evento
    61675
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1505-2012
  • Fecha de inicio del evento
    2012-04-23
  • Fecha de publicación del evento
    2012-05-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108697
  • 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
    Activator, ultraviolet, for polymerization - Product Code EBZ
  • Causa
    Disposa-shield disposable curing shield is recalled due to lacking 510k, pma or ide, and inadequate quality system.
  • Acción
    The firm, O'Ryan Industries Inc., began to contact consignees by telephone and sent email on April 25, 2012. O'Ryan sent a recall notification letter dated May 7, 2012 to their customers through the Purchasing Agents and Order Department Personnel. The letter described the product, problem, and actions to be taken by the customers. Customers were advised to return the Disposa-Shield back to O'Ryan Industries. Customers can call O'Ryan Industries at 800-426-4311 or fax to 360-892-6742.
Retiro De Equipo (Recall) de LifeShield Primary Plumset
  • Tipo de evento
    Recall
  • ID del evento
    61680
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1491-2012
  • Fecha de inicio del evento
    2012-04-25
  • Fecha de publicación del evento
    2012-05-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108703
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
    Pump, infusion - Product Code FRN
  • Causa
    The lifeshield primary plumsets may cause a cassette test failure alarm when the set is loaded onto the infusion pump. a set which results in a cassette test failure alarm may result in delay in therapy, requiring medical intervention.
  • Acción
    Hospira, sent an "URGENT DEVICE RECALL" letter dated April 25, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The customers were instructed to check their inventory and immediately quarantine any affected product to return for credit. A Reply Form was enclosed for customers to complete and return via fax to 1-888-386-2073 or e-mail to: Hospira8503@stericycle.com. Contact Hospira Customer Care at 1-877-946-7747 for information regarding product availability.
Retiro De Equipo (Recall) de 8" x 4" 16ply Dual XRay Gauze
  • Tipo de evento
    Recall
  • ID del evento
    61681
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1518-2012
  • Fecha de inicio del evento
    2012-04-09
  • Fecha de publicación del evento
    2012-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-12-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108705
  • 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
    Gauze/sponge, internal, x-ray detectable - Product Code GDY
  • Causa
    The lots of x-ray gauze are contaminated with foreign material, including remnants of cotton seeds and lint.
  • Acción
    International Medsurg Connection notified their direct accounts via telephone, e-mail and/or fax on April 9, 2012, informing them of the foreign material contamination of the gauze, and requesting them to quarantine all affected lots in inventory, cease distribution of the affected product, and notify any customers at the retail level to remove and discard these products. Any questions were directed to (847) 619-9926.
Retiro De Equipo (Recall) de UltraDriveTool, 6 MM Plug Puller
  • Tipo de evento
    Recall
  • ID del evento
    61685
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1521-2012
  • Fecha de inicio del evento
    2012-04-18
  • Fecha de publicación del evento
    2012-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-04-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108716
  • 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
    Device, nerve conduction velocity measurement - Product Code JXE
  • Causa
    Incorrect product picture label was on the product box.
  • Acción
    Biomet Orthopedics sent an Urgent Medical Device Recall Notice dated April 18,2012, to all affected customers. The letter identified the reason for the recall including directions to immediately locate, discontinue use of the device, and return product to Biomet, 56 East Bell Drive, Warsaw, IN 46580. Consignees were asked to confirm receipt of the notice by calling 1-800-348-9500 extension 3983 or 3009. A FAX Back Response Form was to be filled out and sent within 3 days of receipt to 574-372-1683. Questions related to the notice should be directed to 474-372-3983 or 574-371-3009, Monday- Friday 8 a.m. to 5 p.m. For questions regarding this recall call 574-371-1021.
Retiro De Equipo (Recall) de SIGMASpectrum
  • Tipo de evento
    Recall
  • ID del evento
    61691
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2030-2012
  • Fecha de inicio del evento
    2012-04-23
  • Fecha de publicación del evento
    2012-07-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108723
  • 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
    Sigma is a safety alert for the master drug library (mdl) editor software associated with the sigma spectrum infusion pump system because it may result in a facility drug library that does not represent common clinical practices.
  • Acción
    Sigma sent an Urgent: Customer Safety Alert dated April 23, 2012 via UPS delivery to all consignees requesting both acknowledgement of notification and confirmation that recommended actions have been taken. Customers are asked to follow the instructions contained in the recall letter. Customers with questions may contact the firm at 800-356-3454 ext 300.
Retiro De Equipo (Recall) de BD Phoenix Automated Microbiology System Software for Automated Micr...
  • Tipo de evento
    Recall
  • ID del evento
    61692
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1657-2012
  • Fecha de inicio del evento
    2012-04-10
  • Fecha de publicación del evento
    2012-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108724
  • 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, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Causa
    Bd identified an increase in vancomycin-resistant strains that may exhibit erroneous results on all pmic or pmic/id panels and could lead to ineffective treatment regimen in affected patients.
  • Acción
    Becton Dickinson (BD) sent an Urgent Field Correction Action letter dated April 2012 and an Update letter dated April 18, 2012 to all affected customers via e-mail and UPS overnight delivery. The letter identified the affected products, problem and actions to be taken. The letter provided specific workaround instructions for device users pending software upgrades. A BD Service Engineer will contact affected customers to arrange for the installation of the updated software when it becomes available. The letter included an Acknowledgement Form to be completed. For questions contact Technical Services at 800-638-8663.
Retiro De Equipo (Recall) de BD Phoenix System software update disk
  • Tipo de evento
    Recall
  • ID del evento
    61692
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1658-2012
  • Fecha de inicio del evento
    2012-04-10
  • Fecha de publicación del evento
    2012-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108725
  • 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, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Causa
    Bd identified an increase in vancomycin-resistant strains that may exhibit erroneous results on all pmic or pmic/id panels and could lead to ineffective treatment regimen in affected patients.
  • Acción
    Becton Dickinson (BD) sent an Urgent Field Correction Action letter dated April 2012 and an Update letter dated April 18, 2012 to all affected customers via e-mail and UPS overnight delivery. The letter identified the affected products, problem and actions to be taken. The letter provided specific workaround instructions for device users pending software upgrades. A BD Service Engineer will contact affected customers to arrange for the installation of the updated software when it becomes available. The letter included an Acknowledgement Form to be completed. For questions contact Technical Services at 800-638-8663.
Retiro De Equipo (Recall) de PHADIA VarelisA Cardiolipin IgM Antibodies Assay
  • Tipo de evento
    Recall
  • ID del evento
    62572
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2285-2012
  • Fecha de inicio del evento
    2012-08-02
  • Fecha de publicación del evento
    2012-08-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-12-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111072
  • 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
    in vitro diagnostic - Product Code MID
  • Causa
    Customers were not following the labeled assay procedure. this was due to a letter issued to them in 2004 from phadia gmbh, which indicated that customers could omit the pre-wash step. the omission of the pre-wash step, when combined with a change in material source in kit lot #0067, caused elevated results.
  • Acción
    On 8/2/2012 an URGENT PRODUCT CORRECTION INFORMATION FOR PHADIA VARELISA CARDIOLIPIN IGM, Article Number 15696 letter was sent to all consignees the received the Direction for Use modification letter in 2004.
Retiro De Equipo (Recall) de True Beam
  • Tipo de evento
    Recall
  • ID del evento
    61693
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1495-2012
  • Fecha de inicio del evento
    2012-04-09
  • Fecha de publicación del evento
    2012-05-08
  • 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=108734
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Causa
    A software anomaly has been identified in truebeam when using respiratory gating with patients in the prone position. the gating curve is inverted when a prone patient plan is loaded into truebeam.
  • Acción
    Varian sent an Urgent Medical Device Correction - Urgent Field Safety Notice dated April 13, 2012 to all affected customers. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter identified the affected product, description of problem, details and recommended user actions. Varian will provide a software version that will mitigate the issue described in the letter and Varian Customer Support will notify each affected facility when the software is available. The letter instructs customers to retained a copy of this notice along with the most current product labeling. For future reference, this document will be posted to the Varian Medical Systems customer support website: http://www.MyVarian.com. For questions contact Varian Oncology Help Desk at 1-888-827-4265 US and Canada.
Retiro De Equipo (Recall) de TrueBeam and TrueBeam STx
  • Tipo de evento
    Recall
  • ID del evento
    61694
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1617-2012
  • Fecha de inicio del evento
    2012-04-09
  • Fecha de publicación del evento
    2012-05-16
  • 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=108735
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Causa
    Varian received a report involving a gantry collision and is sending a notification to remind users of the collision protection tools available with truebeam and truebeam stx, including actions the operator should be aware of.
  • Acción
    An "Urgent Medical Device Correction / Field Safety Letter" was distributed to all affected users on April 9, 2012, with a description of the problem and user corrective action steps. The Letter was also distributed to the Varian Sales, Marketing, and Service organizations. Customers in the US and Canada may contact (888) 827-4265 for questions. *** An additional letter was sent on 11/5/12 to additional consignees identified by Varian as being affected the the recall but not previously notified.
Retiro De Equipo (Recall) de Celsus Foot
  • Tipo de evento
    Recall
  • ID del evento
    61701
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1650-2012
  • Fecha de inicio del evento
    2012-04-05
  • Fecha de publicación del evento
    2012-05-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108756
  • 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
    Component, external, limb, ankle/foot - Product Code ISH
  • Causa
    An incorrect shorter part ( pyramid) was installed in the foot. a foot of this size and configuration requires a longer pyramid. customers requiring the extra firm configuration may have a minimal risk of component failure, which could be implicated in a potential fall.
  • Acción
    All customers who received affected product were initially contacted via phone on April 5, 2012 and made aware of the recall, including instructions to notify customers immediately and arrange replacements. A "Recall Notice" letter dated April 24, 2012 was sent to customers describing the problem and the recommended actions. Contact reference person is Kimberly Light, 1 800-728-7950, info@college-park.com.
Retiro De Equipo (Recall) de Kryptonite Bone Cement
  • Tipo de evento
    Recall
  • ID del evento
    61709
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1496-2012
  • Fecha de inicio del evento
    2012-04-06
  • Fecha de publicación del evento
    2012-05-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108767
  • 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
    Methyl methacrylate for cranioplasty - Product Code GXP
  • Causa
    Bone cement strength and stiffness fall below specification at body temperature.
  • Acción
    Doctors Research Group (DRG) issued a Voluntary Product Recall Notification letter dated April 2012 to all affected customers via email or Federal Express. The letter identified the affected product, problem and actions to be taken. Customers were instructed to identify, segregate and return any affected products in their possession. Customers were asked to fill out and return the enclosed verification form Distributors were requested to notify their customers. For questions contact DRG at 203-262-9335.
Retiro De Equipo (Recall) de Transhepatic Biliary Stent System
  • Tipo de evento
    Recall
  • ID del evento
    61713
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1507-2012
  • Fecha de inicio del evento
    2012-04-09
  • Fecha de publicación del evento
    2012-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-12-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108774
  • 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, biliary, diagnostic - Product Code FGE
  • Causa
    Cordis corporation is recalling 32 lots of cordis s.M.A.R.T. nitinol stent transhepatic biliary system and s.M.A.R.T. control nitinol stent transhepatic biliary system. there is a potential for a sterility breach due to holes or tears in the tyvek packaging.
  • Acción
    Cordis Corp sent a " Urgent Medical Device Recall (Removal) letter dated April 9, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A Response Form was provided with each notification. Customers were asked to complete and return Response Form. The customers were instructed to : " Immediately identify and set aside all product listed above in a manner that ensures the affected product will not be used. " Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form. " Either return any affected product with reference to the RA# on the form, or contact your local sales representative, or contact Customer Service (see Available Assistance section) to facilitate return of the affected product. Replacement product will be provided in a short time frame. Credit will be provided for customer-owned inventory upon request. " Pass on this notice to anyone in your facility that needs to be informed. " If any product listed below has been forwarded to another facility, contact that facility to arrange return. " Maintain awareness of this notice until all product listed above has been returned to Cordis. For questions related to the issue or product replacement, please contact your local sales representative, or contact the special Customer Service number (800) 551-7683, Monday through Friday from 8:30 AM to 8:00 PM EDT.
  • « First
  • ‹ Prev
  • …
  • 2
  • 3
  • 4
  • 5
  • 6
  • …
  • 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.

Descargar la data

La International Medical Devices Database está bajo la licencia Open Database License y sus contenidos bajo la licencia Creative Commons Attribution-ShareAlike . Al usar esta data, siempre citar al International Consortium of Investigative Journalists. Puede descargar acá una copia de la base de datos.

Descargar todo (zipped)