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  • Dispositivo 3
  • Fabricante 3
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de Cardiovascular
  • Tipo de evento
    Recall
  • ID del evento
    15
  • Fecha
    2014-02-11
  • País del evento
    South Korea
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    Accepted 05-251
Retiro De Equipo (Recall) de PLUM A+ VOLUMETRIC INFUSION PUMP
  • Tipo de evento
    Recall
  • ID del evento
    17338
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2011-02-21
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
    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
  • Causa
    Hospira has received customer reports of the plum a+ infusion pumps with no audible alarm conditions which have been associated with failure of the piezoelectric assembly due to component quality issues.
Retiro De Equipo (Recall) de LANTIS INFORMATION MANAGEMENT SYSTEM - RECORD AND VERIFICATION
  • Tipo de evento
    Recall
  • ID del evento
    17342
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-07-04
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    When using sequencer with the lantis oncology information system the error comes up if lantis cannot insert a new record.
Retiro De Equipo (Recall) de SCORPIO PATELLA ASSEMBLY INSTRUMENT
  • Tipo de evento
    Recall
  • ID del evento
    17346
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-08-03
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Stryker orthopaedics has received reports of disassociated components of the scorpio patella assembly instrument. an investigation revealed that the press-fit specifications between the pin(s) and either one or both clamping subcomponents were not met.
Retiro De Equipo (Recall) de SCORPIO NRG KNEE SYSTEM - CRUCIATE RETAINING FEMORAL COMPONENT WITH ...
  • Tipo de evento
    Recall
  • ID del evento
    17347
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-08-28
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    A packaging discrepancy was identified in specific lots of stryker's scorpio femoral packaging. it was found that the peel strength of the inner blister may have been below internal validated requirements.
Retiro De Equipo (Recall) de ELEKTA SYNERGY PLATFORM
  • Tipo de evento
    Recall
  • ID del evento
    17350
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2008-03-21
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    A touchgard feature has been added to the elekta synergy kv source to further enhance the safety greatures of the elekta synergy system.
Retiro De Equipo (Recall) de HEALON ENDOCOAT
  • Tipo de evento
    Recall
  • ID del evento
    17354
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-11-18
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    This recall results from complaints received in the united states regarding the detachment of the healon endocoat opthalmic viscoelastic device (ovd) finger grip. an advisory notice is being disseminated to customers to re-emphasize proper techniques for the use of the syringe included in the healon endocoat directions for use (dfu).
Retiro De Equipo (Recall) de LEGIONELLA GROWTH SUPPLEMENT
  • Tipo de evento
    Recall
  • ID del evento
    17355
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-08-28
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    The supplement may contain low level microbial contamination which could result in incorrect results reporting.
Retiro De Equipo (Recall) de CUSA EXCEL SYSTEM - CONSOLE
  • Tipo de evento
    Recall
  • ID del evento
    17356
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2002-02-13
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Part of the lot may not have been sterilized.
Retiro De Equipo (Recall) de CONTAK RENEWAL 4 CRT-D
  • Tipo de evento
    Recall
  • ID del evento
    17357
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2006-05-16
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Guidant has recieved 2 reports of device malfunction associated with subpectoral implantation in an uncommon orientation.
Retiro De Equipo (Recall) de OMNIBED
  • Tipo de evento
    Recall
  • ID del evento
    17361
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2002-12-10
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Manufacturer has determined that these devices under certain conditions cause leakage currents in excess of specifications as well as complaints of short life of power failure back-up battery.
Retiro De Equipo (Recall) de INTELLIVUE - INFORMATION CENTER IX - SOFTWARE
  • Tipo de evento
    Recall
  • ID del evento
    17365
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-06-10
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    It was determined that a health canada medical device licence amendment application was required on piic ix b.01 products shipping to canada because the operating system (os) was changed from windows 7 to windows 8.1.
Retiro De Equipo (Recall) de CENTRICITY LABORATORY - CORE LAB
  • Tipo de evento
    Recall
  • ID del evento
    17366
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-08-30
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Software error where when the user set micro_correct_msg_type and correct_msg_type to different variables in microbiology result entry when released results are changed and the correct results mesages are edited on the free-text form some of the originally entered panel free-text is lost.
Retiro De Equipo (Recall) de TD-SYNERGY
  • Tipo de evento
    Recall
  • ID del evento
    17368
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2007-12-07
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Mismatch could occur between the demographic data of 2 patients when they are replicated from the production database to the relational database.
Retiro De Equipo (Recall) de SECURE MED/SURG BED MODEL 3000
  • Tipo de evento
    Recall
  • ID del evento
    17375
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2002-02-26
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Boulons tenant les barrieres en place peuvent se devisser apres un certain temps celles-ci devenant instables pourraient causer la chute d'un patient.
Retiro De Equipo (Recall) de IMMUNO 1 - TROPONIN I ASSAY
  • Tipo de evento
    Recall
  • ID del evento
    17376
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2002-04-29
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Complaints received of low recoveries on immuno 1 troponin i reagent.
Retiro De Equipo (Recall) de ADVIA CENTAUR SYSTEM - BR (27.29) ASSAY
  • Tipo de evento
    Recall
  • ID del evento
    17377
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-09-04
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Reports received for quality control results outside of the expected ranges.
Retiro De Equipo (Recall) de INTELLISPACE PORTAL DX
  • Tipo de evento
    Recall
  • ID del evento
    17378
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-02-15
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Philips healthcare has become aware that a software issue may cause misdiagnosis when using the uniform resource locator (url) pacs integration. when loading a study to an analysis application while using url pacs integration configuration after another study was opened by a review application the analysis monitor is updated with the study of the current patient but the review monitor continues to display the study from the previous patient.
Retiro De Equipo (Recall) de AXSYM SYSTEM - TOTAL B-HCG ASSAY
  • Tipo de evento
    Recall
  • ID del evento
    17597
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2004-08-11
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Manufacturer has received a number of complaints for calibration failures due to calibration code 1048 and results in invalid calibration curves.
Retiro De Equipo (Recall) de AFFINITY FOUR BIRTHING BEDS P3700B
  • Tipo de evento
    Recall
  • ID del evento
    17381
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2008-07-25
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    On august 16 2007 hill rom discovered in manufacturing a change was made to one of the key components of the brake system which compromised the effectiveness of the brake function holding and locking capabilit.
Retiro De Equipo (Recall) de WALLACH LL100/LL50X
  • Tipo de evento
    Recall
  • ID del evento
    17392
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-03-23
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Coopersurgical has determined that one of the internal gas lines may malfunction causing the line to burst under pressure.
Retiro De Equipo (Recall) de CLOSED CAMERA SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    17397
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2004-07-19
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Product may come apart if excessive force is applied to slide gate.
Retiro De Equipo (Recall) de SURGICAL MICROSCOPE FOOTSWITCH
  • Tipo de evento
    Recall
  • ID del evento
    17409
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-03-29
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Received twelve (12) complaints stating that the pedals of the footswitch/wireless type b are sticking and the zoom/focus is moving to the end position striking the patient's eye and potentially causing injury when a non-contact viewing system is attached.
Retiro De Equipo (Recall) de BD BACTECT FX SYSTEM BOTTOM
  • Tipo de evento
    Recall
  • ID del evento
    17413
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-12-17
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Bd has determined that some bd bactec fx instruments contain racks that may demonstrate variable indicator light intensities. specifically the anonymous vial indicator lights which should appear yellow may instead appear more green in color.
Retiro De Equipo (Recall) de MR APPLICATIONS
  • Tipo de evento
    Recall
  • ID del evento
    17414
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-08-19
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Cardiacvx and cardiacvx flow report higher than actual flow values on phase-contrast images acquired with magnitude weighting mask enabled. note that this issue can only occur on phase contrast mr protocols with the magnitude weighting mask option enabled. in the fast cine phase-contrast sequence the magnitude weighting mask is a user configurable option (control variable or cv). in the 2d cine phase-contrast sequence (non-fast mode) magnitude weighting mask is always on and thus would always result in this issue. the issue may result in an incorrect diagnosis if higher than actual flow values are not noticed.
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