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  • Dispositivo 26
  • Fabricante 14
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de Device Recall NexGen Complete Knee Solution
  • Tipo de evento
    Recall
  • ID del evento
    65413
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2008-2013
  • Fecha de inicio del evento
    2013-06-07
  • Fecha de publicación del evento
    2013-08-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118829
  • 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
    Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
  • Acción
    Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany. " Communications outside of the United States will occur approximately two weeks after the United States communications.
Retiro De Equipo (Recall) de Device Recall NexGen Complete Knee Solution
  • Tipo de evento
    Recall
  • ID del evento
    65413
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2009-2013
  • Fecha de inicio del evento
    2013-06-07
  • Fecha de publicación del evento
    2013-08-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118831
  • 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
    Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
  • Acción
    Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany. " Communications outside of the United States will occur approximately two weeks after the United States communications.
Retiro De Equipo (Recall) de Device Recall Asante Conset Infusion Set
  • Tipo de evento
    Recall
  • ID del evento
    66895
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0600-2014
  • Fecha de inicio del evento
    2013-11-19
  • Fecha de publicación del evento
    2013-12-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124078
  • 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
    Set, administration, intravascular - Product Code FPA
  • Causa
    Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
  • Acción
    Asante sent urgent medical device recall notifications letters to distributors and customers on November 19, 2013 by US mail, return receipt requested.
Retiro De Equipo (Recall) de Device Recall NexGen Complete Knee Solution
  • Tipo de evento
    Recall
  • ID del evento
    65413
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2010-2013
  • Fecha de inicio del evento
    2013-06-07
  • Fecha de publicación del evento
    2013-08-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118836
  • 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
    Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
  • Acción
    Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany. " Communications outside of the United States will occur approximately two weeks after the United States communications.
Retiro De Equipo (Recall) de Device Recall NexGen Complete Knee Solution
  • Tipo de evento
    Recall
  • ID del evento
    65413
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2011-2013
  • Fecha de inicio del evento
    2013-06-07
  • Fecha de publicación del evento
    2013-08-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118842
  • 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
    Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
  • Acción
    Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany. " Communications outside of the United States will occur approximately two weeks after the United States communications.
Retiro De Equipo (Recall) de Device Recall Maquet
  • Tipo de evento
    Recall
  • ID del evento
    65417
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1572-2013
  • Fecha de inicio del evento
    2013-05-14
  • Fecha de publicación del evento
    2013-06-21
  • 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=118859
  • 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
    Cannula injections - Product Code FGY
  • Causa
    The specified part numbers and lot numbers of maquet pediatric arterial cannula packs may contain an incorrectly sized connector.
  • Acción
    Maquet sent an "Urgent Product Recall"/"Recall - Device Corrective Action Response" forms dated May 14, 2013, via Federal Express to all affected customers. The notification identifies affected product; informs customers of the nature of the issue; advises of potential adverse patient consequences that may occur; and advises customers to follow instructions on the "Recall-Device Corrective Action Response" forms included as part of the notification. If you have any further questions please contact your local MAQUET representative or call Customer Service at (888) 627-8383.
Retiro De Equipo (Recall) de Device Recall Siemens MEVATRON series, PRIMART (limited release)PRI...
  • Tipo de evento
    Recall
  • ID del evento
    65418
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1663-2013
  • Fecha de inicio del evento
    2013-05-29
  • Fecha de publicación del evento
    2013-07-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-01-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118861
  • 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
    The information regarding the film mode calibration may have been considered difficult to interpret when translated. siemens healthcare cr / radiation oncology had become aware that this issue may have resulted in mistreatment of patients.
  • Acción
    Siemens sent an "URGENT: MEDICAL DEVICE CORRECTION" letter and Update instruction TH022/13/S beginning on May 29, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. July 19, 2013 - TH023/13/S was distributed is now in progress. This is the FILM Mode Physics Primer Addendum.
Retiro De Equipo (Recall) de Device Recall Lithium Thionyl nonrechargeable disposable battery pack
  • Tipo de evento
    Recall
  • ID del evento
    65423
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1645-2013
  • Fecha de inicio del evento
    2011-05-02
  • Fecha de publicación del evento
    2013-07-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118870
  • 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
    Transmitters and receivers, physiological signal, radiofrequency - Product Code DRG
  • Causa
    Braemar inc., became aware of a battery related incident that occurred with an able battery pack being used in a braemar er920w wireless event monitor. the event did not result in any patient related injury or present any clinical impact.
  • Acción
    Braemar began notifying customers by telephone on 5/2/2011. Braemar issued Advisory Notice letter P/N 600-0662-00 RevA dated May 16, 2011. The letter was sent by UPS to all consignees.The letter described the problem and the product involved in the recall. Consignees were advised not to use the battery pack in the Braemar ER920W or Braemar Fusion device and requested consignees to complete and return the Verification Form. For questions regarding this recall call 651-286-8620.
Retiro De Equipo (Recall) de Device Recall MedStream Programmable Infusion Pump
  • Tipo de evento
    Recall
  • ID del evento
    65420
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1690-2013
  • Fecha de inicio del evento
    2013-06-07
  • Fecha de publicación del evento
    2013-07-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-04-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118879
  • 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, implanted, programmable - Product Code LKK
  • Causa
    Miscalibrated fill level sensor may affect dosing level.
  • Acción
    Codman issued a Medical Device Correction Notification to Medical Facilities dated June 7, 2013 via FedX to inform them of the potential problem and a Worksheet (instructions) to Identify Pumps with Miscalibrated FLS during each patient's next scheduled refill session or sooner if patient is symptomatic. If a pump is identified as having a miscalibrated FLS, notify Codman Neuro using the same worksheet. In addition a sample letter was provided to Physi cans to provide to patients on the system. Follow the recommendations for managing patients who are identified as having a pump with a miscalibrated FLS. For additional information,contact your Codman Neuro representative, or contact Codman Neuro Clinical Support at 1-800-660-2660. Please report any malfunction or adverse event related to this device to Codman Neuro at 1-866-491-0974, Option 2.
Retiro De Equipo (Recall) de Device Recall SynchroMed II Implantable Infusion Pump
  • Tipo de evento
    Recall
  • ID del evento
    65135
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1571-2013
  • Fecha de inicio del evento
    2013-06-03
  • Fecha de publicación del evento
    2013-06-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-05-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118880
  • 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, implanted, programmable - Product Code LKK
  • Causa
    Medtronic is providing healthcare professionals with important safety information and patient management recommendations regarding the unintended delivery of drug during the priming bolus function for the synchromed implantable infusion pump. the unintended delivery of drug can contribute to patient overdose or underdose symptoms which may be clinically relevant.
  • Acción
    Medtronic sent an Urgent Medical Device Correction letter dated May 2013, to all affected customers. The letter described the background and nature of the issue and provided recommendations for patient management and monitoring after initiation of Intrathecal Therapy. The letter directed customers to continue to use the priming bolus precedure; to monitor all patients following start or restart of intrathecal therapy; consider priming the pump prior to implant; and educate caregivers and family members to recognize the signs and sypmtoms associated with intrathecal drug therapy complications. For questions contact your local Medtronic field representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933.
Retiro De Equipo (Recall) de Device Recall Medtronic MiniMed Paradigm Insulin Infusion Sets
  • Tipo de evento
    Recall
  • ID del evento
    65430
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1668-2013
  • Fecha de inicio del evento
    2013-06-07
  • Fecha de publicación del evento
    2013-07-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118883
  • 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
    Set, administration, intravascular - Product Code FPA
  • Causa
    Medtronic is recalling the medtronic minimed paradigm medtronic is recalling the medtronic minimed paradigm insulin infusion sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of medtronic paradigm infusion sets. under certain conditions, the infusion set may malfunction and deliver an incorrect volume of insulin.
  • Acción
    Medtronic, Inc. sent an Urgent Medical Device Safety Notification letter dated June 10, 2013, to all affected consignees. The letter identified the product and notified healthcare professionals of the potential for over or under delivery of insulin if insulin or other fluids contact the inside of Medtronic Paradigm Tubing Connectors. The letter informed the consignees that it applies to all Medtronic infusion sets designed for use with Medtronic Paradigm family infusion pumps. Paradigm Insulin Pump users, distributors, and healthcare professionals were all instructed to contact Medtronic's 24 hour helpline at (888) 204-7616. For questions regarding this recall call 818-567-4700.
Retiro De Equipo (Recall) de Device Recall BD MAX Instrument
  • Tipo de evento
    Recall
  • ID del evento
    65431
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1662-2013
  • Fecha de inicio del evento
    2013-05-31
  • Fecha de publicación del evento
    2013-07-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118884
  • 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
    Nucleic acid amplification assay system, group b streptococcus, direct specimen test - Product Code NJR
  • Causa
    Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.
  • Acción
    Becton Dickinson (BD) notified their customers in the US by phone on May 31, 2013 and by an Urgent Field Correction Action letter dated May 2013. Customers were advised of the affected product, problem and actions to be taken. The letter informed customers that an onsite visit by a BD Service representative is planned to perform a system check so to determine if the instrument is affected. BD's field service team plans to immediately replace the module on site if the affected part is found. For questions contact BD Technical Services Department at 1-800-638-8663.
Retiro De Equipo (Recall) de Device Recall SLIFT
  • Tipo de evento
    Recall
  • ID del evento
    65429
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1665-2013
  • Fecha de inicio del evento
    2013-05-24
  • Fecha de publicación del evento
    2013-07-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118885
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Causa
    The outer sleeve would not fit over the s-lift inserter assembly because the hole at the top of the sleeve handle was too small.
  • Acción
    Spine Frontier sent an Urgent Advisory Notice letter dated On June 7, 2013 to all consignees via email. The letter identified the affected product, problem and actions to be taken. The letter informed consignees that a modification has been implemented to the Outer Sleeve component of the S-LIFT Inserter and that SpineFrontier has initiated removal of the affected product from the field.. An acknowledgement form is to be signed and returned from each recipient of the Advisory Notice. Upon receipt of the acknowledgement form and RMA request for part return, replacement parts will be shipped. For questions call 978-232-3990.
Retiro De Equipo (Recall) de Device Recall NexGen Complete Knee Solution
  • Tipo de evento
    Recall
  • ID del evento
    65413
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2012-2013
  • Fecha de inicio del evento
    2013-06-07
  • Fecha de publicación del evento
    2013-08-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118900
  • 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
    Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
  • Acción
    Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany. " Communications outside of the United States will occur approximately two weeks after the United States communications.
Retiro De Equipo (Recall) de Device Recall Medtronic, Consulta CRTP, Syncra CRTP
  • Tipo de evento
    Recall
  • ID del evento
    65433
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1607-2013
  • Fecha de inicio del evento
    2013-06-07
  • Fecha de publicación del evento
    2013-06-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118886
  • 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
    Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) - Product Code NKE
  • Causa
    Medtronic recently identified an issue with a subset of consulta¿ crt-p and syncra¿ crt-p devices during production. as of may 30, 2013, there have been no reported or confirmed device failures. however, because of the potential for malfunction, medtronic is requiring the return of non-implanted devices manufactured between april 1 and may 13, 2013 for re-inspection. the issue is unique to specifi.
  • Acción
    Medtronic sent an Urgent Medical Device Recall letter dated June 7, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to immediately return non-implanted devices to Medtronic and to register the implanted ones immediately by calling the Medtronic Patient Registration Department at 1-800-848-9300. Customers with questions were instructed to contact their local Medtronic representative or Medtronic Customer Service at 1-800-848-9300. For questions regarding this recall call 763-526-6000. UPDATE: An Urgent Medical Device Correction letter, dated June 2013, was sent to affected implanting and following physicians beginning June 28, 2013. In the US these letters were hand delivered by a Medtronic representative. Outside the US, the notice will be mailed or hand delivered as determined by the geographic center. The letter informed physicians that they have implanted or are following a patient implanted with a device potentially affected by the connector bracket weld issue. The letter described how a loss of hermeticity may affect the device functionality and what symptoms a patient may experience. The letter also offers patient management recommendations.
Retiro De Equipo (Recall) de Device Recall SIEMENS ARTISTE
  • Tipo de evento
    Recall
  • ID del evento
    65435
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1562-2013
  • Fecha de inicio del evento
    2013-05-29
  • Fecha de publicación del evento
    2013-06-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-11-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118888
  • 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
    The potential for a safety issue, for the image quality degradation, that is addressed by the customer safety advisory notice when verifying the patient position based on 2d images that were acquired as single-exposure mv or in-line kview images using the syngo rt therapist 4.3.
  • Acción
    Siemens sent an Urgent: Medical Device Correction Customer Safety Advisory Notice letter to all affected customers. The letter identified the affected product, problem, what preventive measures can the user take and actions to be taken. Customers were advised to perform the preventive measures provided and inform all affected personnel immediately. The letter states that Siemens is currently working on a new version of the software. Customers are asked to include the Customer Safety Advisory Notice in the System Owner Manual chapter "Safety Advisory Letters". For question call 925-602-8157.
Retiro De Equipo (Recall) de Device Recall Echelon, Echelon Oval and Oasis MR imaging device sy...
  • Tipo de evento
    Recall
  • ID del evento
    65438
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1559-2013
  • Fecha de inicio del evento
    2013-01-31
  • Fecha de publicación del evento
    2013-06-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118892
  • 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, nuclear magnetic resonance imaging - Product Code LNH
  • Causa
    Hitachi discovered a software error that can occur when simultaneously scanning a patient while processing images previously acquired from a different patient. the software error can occur randomly. the error causes an image in the processed dataset to have the same unique identifier (uid) as in the scanning dataset. the processed image is stored in the place of the original image, which is lost.
  • Acción
    Hitachi sent a Device Correction Notice beginning on January 31,2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Software correction is targeted to start by March 1, 2013. All sites will be visited by Hitachi Service to perform corrections. All letters are recorded by tracking number and date received by the customers. For further questions please call 800-800-3106 x 3720.
Retiro De Equipo (Recall) de Device Recall SLIFT
  • Tipo de evento
    Recall
  • ID del evento
    65432
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1664-2013
  • Fecha de inicio del evento
    2013-05-17
  • Fecha de publicación del evento
    2013-07-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-05-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118893
  • 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
    Tray, surgical, instrument - Product Code FSM
  • Causa
    The s-lift instrument case contained a bracket with peeling nylon coating.
  • Acción
    Spine Frontier sent an Urgent Advisory Notice letter dated On June 7, 2013 to all consignees via email. The letter identified the affected product, problem and actions to be taken. The letter informed customers that a modification has been implemented for the improved durability of S-LIFT Case Brackets and that SpineFrontier has initiated removal of these cases from the field. An acknowledgement form is to be signed and returned from each recipient of the Advisory Notice. Upon receipt of the acknowledgement form and RMA request for part return, replacement parts will be shipped. For questions call 978-232-3990.
Retiro De Equipo (Recall) de Device Recall RITA Main Cable
  • Tipo de evento
    Recall
  • ID del evento
    65439
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1675-2013
  • Fecha de inicio del evento
    2013-06-11
  • Fecha de publicación del evento
    2013-07-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118894
  • 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 rita main cable product contains the incorrect instructions for use.
  • Acción
    Consignees were notified via certified mail on 06/11/2013 with an "Urgent Medical Device Field Safety Correction" notification. This included the correct Instructions for Use and the recommended actions.
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