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Vista de la lista Vista de las tarjetas
  • Dispositivo 183
  • Fabricante 87
  • Evento 124969
  • Implante 15
Retiro De Equipo (Recall) de EPIC II VR
  • Tipo de evento
    Recall
  • ID del evento
    153186
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2008-01-16
  • 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
    A loss of ventricular sensing would prevent an icd from being able to detect an arrhythmia.
Retiro De Equipo (Recall) de SCALE ADAPTERS
  • Tipo de evento
    Recall
  • ID del evento
    153190
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-07-08
  • 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
    If you twist the sling bar when using the scale and scale adapter at a right angle in the lifting direction the adapter can get locked in this position when the lift has a flexlink. if patient is lifted with the equipment while adapter is in this position adapter may be damaged or break allowing a patient to fall.
Retiro De Equipo (Recall) de ACCESS SYSTEM - PROGESTERONE ASSAY
  • Tipo de evento
    Recall
  • ID del evento
    153191
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2008-04-09
  • 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
    Progesterone analytical sensitivity & male reference range insert claims and dilution recovery are not consistently met. failure to meet analytical sensitivity claim is limited to dxl platform.
Retiro De Equipo (Recall) de SORIN BLOOD CARDIOPLEGIA CONSOLE
  • Tipo de evento
    Recall
  • ID del evento
    153213
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    1999-03-18
  • 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
    Units may speed up to an unspecified excessive speed and the pump could only be shut down by turning off the main power switch.
Retiro De Equipo (Recall) de STOCKERT HEATER COOLER SYSTEM 3T - MAIN UNIT
  • Tipo de evento
    Recall
  • ID del evento
    153219
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-06-30
  • 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
    Livanova has determined that certain oxygenators containing a heat-exchanger with a polymer membrane separating the blood compartment from the water compartment when used with the cleaning an disinfection regimen described in the ifu for the heater cooler system 3t (ifu versions applicable since 2013) may result in diffusion of a small quantity of hydrogen peroxide from the water side to the blood side during a typical procedure in a quantity that exceeds the allowable limits determined by livanova.
Retiro De Equipo (Recall) de VEIN GRAFT CANNULA
  • Tipo de evento
    Recall
  • ID del evento
    153227
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    1996-06-14
  • 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
Retiro De Equipo (Recall) de IQMANAGER DIAGNOSTIC WORKSTATION SOFTWARE
  • Tipo de evento
    Recall
  • ID del evento
    153230
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2011-04-08
  • 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
    Midmark diagnostics has initiated a field corrective action to inform customers that the iqmanager diagnostic workstation software did not perform as intended.
Retiro De Equipo (Recall) de SHERIDAN PREFORMED CUFFED TRACHEAL TUBES NASAL WITH MURPHY EYE
  • Tipo de evento
    Recall
  • ID del evento
    153231
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2006-10-17
  • 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
    The manufacturer (teleflex medical) has identified that the device did not pass validated sterility test requirements.
Retiro De Equipo (Recall) de ACS:180 CHEMILUMINESCENCE SYSTEM - VALPROIC ACID TEST KIT
  • Tipo de evento
    Recall
  • ID del evento
    153551
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2002-10-09
  • 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
    Some of the solid-phase vials were possibly exposed to light resulting in a potential for significant changes in test results.
Retiro De Equipo (Recall) de EXTENSION SET WITH STOPCOCK AND INTERLINK INJECTION SITES
  • Tipo de evento
    Recall
  • ID del evento
    153232
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-09-10
  • 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
    During packaging testing baxter observed tears and pinholes in chevron-style pouches for certain infusion disposable products. pinholes and tears could compromise the sterile barrier properties of the pouch.
Retiro De Equipo (Recall) de HAMO VISION SINGLE-CHAMBER WASHER/DISINFECTOR
  • Tipo de evento
    Recall
  • ID del evento
    153346
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2010-11-12
  • 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
    Steris has learned that vision sc washer occasionally experience bent spray arms broken or clogged spray arm tips and/or damaged drying piston valves.
Retiro De Equipo (Recall) de AEROSOL MASK
  • Tipo de evento
    Recall
  • ID del evento
    153347
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-02-23
  • 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
    There could be a sticky substance on the inside and/or outside of the mask that may manifest 6 to 8 months after manufacturing of the product.
Retiro De Equipo (Recall) de FT4 II (FREE THYROXINE II)
  • Tipo de evento
    Recall
  • ID del evento
    153350
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-05-12
  • 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
    In the software screens on cobas e 602 the expiry date of ft4 ii reagent kit lot 188609 could be displayed 11/2016 instead of the correct date 10/2016 which is the expiry date of the box and the reagetn kit label. when this occurs the false expiry date is used with the reagetn kits.
Retiro De Equipo (Recall) de RAYSTATION
  • Tipo de evento
    Recall
  • ID del evento
    153354
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-01-24
  • 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
    Issue found with accelerated computation on nvidia gpu (graphic processing unit) in raystation 4.5 raystation 4.7 raystation 5 and raystation 6 when used in a non-standard citrix environment where the gpu settings are configured with a virtual "citrix" graphics board (graphics card).
Retiro De Equipo (Recall) de MINICAP XP WORKSTATION
  • Tipo de evento
    Recall
  • ID del evento
    153358
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2002-10-09
  • 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
    Images may appear flipped under certain conditions.
Retiro De Equipo (Recall) de SYNCHRON LX20 SYSTEM ANALYZER - CLASS 2
  • Tipo de evento
    Recall
  • ID del evento
    153359
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2002-05-20
  • 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 can produce low results on the assays performed on the cartridge chemistry portion of synchron lx systems.
Retiro De Equipo (Recall) de COBAS MPX
  • Tipo de evento
    Recall
  • ID del evento
    153360
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-05-23
  • 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
    Following internal investigation the manufacturer identified a situation where under specific conditions there is a possibility that target specific results sent to a customer lis may not match those results displayed on the cobas 6800-8800 user interface (ui).
Retiro De Equipo (Recall) de 45CM LAPAROSCOPIC TRAY
  • Tipo de evento
    Recall
  • ID del evento
    153554
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-06-10
  • 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
    During a review and retest of the sterilization parameters stryker endoscopy discovered that the 132oc gravity steam sterilization cycle did not consistently sterilize all of the products in the tray.
Retiro De Equipo (Recall) de DISCOVERY MR750 MR SYSTEM - MAIN UNIT
  • Tipo de evento
    Recall
  • ID del evento
    153366
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-07-06
  • 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
    1) inline post-processed (i.E. automated postprocessing) image locations are not correctly annotated under some conditions. 2) reference images displayed in functool fibertrak do not match with the orientation annotations under some conditions.
Retiro De Equipo (Recall) de SYTEC6000
  • Tipo de evento
    Recall
  • ID del evento
    153380
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-03-05
  • 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 x-ray leakage from the diagnostic source assembly (tube+collimator) of the zj/qj families of computed tomography systems exceeded 21cfr regulatory requirement and iec standard.
Retiro De Equipo (Recall) de ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM - MAIN UNIT
  • Tipo de evento
    Recall
  • ID del evento
    153384
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2009-04-24
  • 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 performing a tee exam with the v5ms transducer cw (continuous wave) mode is not functional. a waveform signal cannot be detected. this event occurs on every attempt to acquire a cw signal.
Retiro De Equipo (Recall) de MEDULLARY REAMER HEAD
  • Tipo de evento
    Recall
  • ID del evento
    153389
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-12-08
  • 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 affected part number (352.135) and lot (f-17180) listed is etched as dimension 13.5mm while the actual dimension is 14mm.
Retiro De Equipo (Recall) de ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM - MAIN UNIT
  • Tipo de evento
    Recall
  • ID del evento
    153398
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2010-08-26
  • 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
    Have determined that there is an error in the estimation of mean pressure gradient in the cardiac measurement package available on acuson s2000 systems.
Retiro De Equipo (Recall) de 1.5T SIGNA HDX MR SYSTEM - MAIN UNIT
  • Tipo de evento
    Recall
  • ID del evento
    153402
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-10-15
  • 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
    If gradient cables are inadvertently swapped while servicing and geometry check not performed as required in procedure images may be flipped left-right with incorrect orientation annotation.
Retiro De Equipo (Recall) de COULTER LH 700 SERIES PAK
  • Tipo de evento
    Recall
  • ID del evento
    153408
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2003-02-03
  • 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
    Inadequate description in trouble shooting procedure in training manual.
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