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  • Dispositivo 21
  • Fabricante 17
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de ADVIA CENTAUR XP SYS-HIV AG/AB COMBO (CHIV) ASSAY (DONOR SCREEN TRAN...
  • Tipo de evento
    Recall
  • ID del evento
    23494
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-03-28
  • 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
    Siemens healthcare diagnostics has confirmed that certain samples may show human anti-mouse antibodies (hama) interference for the advia centaur hiv ag/ab combo (chiv) assay. heterophilic antibodies in human serum can react with reagent immunoglobulins interfering with in vitro immunoassays. patients routinely exposed to animals or animal serum products are prone to this interference and anomalous values may be observed. additional information may be required for diagnosis.
Retiro De Equipo (Recall) de AEROSET SYSTEM - PHOSPHORUS ASSAY
  • Tipo de evento
    Recall
  • ID del evento
    23495
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2007-02-07
  • 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
    Assay may produce reults that recover low for urine application at concentrations greater than 20mg/dl. patient samples could be affected by this issue. affects lots 42020hw00 and 44037hw00.
Retiro De Equipo (Recall) de ARTIS ZEEGO MULTI-AXIS
  • Tipo de evento
    Recall
  • ID del evento
    23496
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-06-11
  • 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
    The hand switch to release a x-ray image at the patient table is equipped with a cable extension inside the table. a problem may occur if the connection between cable connection and hand switch is contaminated with an extraordinary large amount of fluid. in a worst case situation uncontrolled release of a x-ray image may happen. if this situation occurs the system terminates uncontrolled x-ray after a short period.
Retiro De Equipo (Recall) de CHOLESTEROL ASSAY
  • Tipo de evento
    Recall
  • ID del evento
    23499
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2010-11-10
  • 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
    Genzyme diagnostics has determined that there was a label error for the cholesterol assay kit. the labels on the kit components for lot 37772 were reversed. colour reagent (r1) label was on the phenol reagent and phenol reagent (r2) label was on the colour reagent. label error will not affect test results as long as components of this lot are not interchanged with components from other lots.
Retiro De Equipo (Recall) de KRYPTONITE BONE CEMENT
  • Tipo de evento
    Recall
  • ID del evento
    23503
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2009-10-23
  • 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
    As a result of increased viscosity of component "a" in some kryptonite bone cement kits the end user may observe difficulty in discharging component "a" from the syringe that it is packaged in.
Retiro De Equipo (Recall) de BENNETT MAMMOGRAPHIC X-RAY SYSTEM MODEL CM205
  • Tipo de evento
    Recall
  • ID del evento
    23505
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    1997-09-24
  • 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
Retiro De Equipo (Recall) de BURN RELIEF - BODY TOWEL
  • Tipo de evento
    Recall
  • ID del evento
    23506
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-10-16
  • 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
    Fabricator could not provide testing records to demonstrate continued validity of the sterilization dose for the burn relief products.
Retiro De Equipo (Recall) de ALL FLOW PULMONARY FUNCTION FILTER
  • Tipo de evento
    Recall
  • ID del evento
    23508
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-11-20
  • 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
    Manufacturer alliance tech medical issued a voluntary recall in response to consumer complaints of bad taste associated with their all flow pulmonary function testing filters.
Retiro De Equipo (Recall) de ECLIPSE
  • Tipo de evento
    Recall
  • ID del evento
    23510
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2004-07-26
  • 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
    The enhanced dynamic wedge (edw) calculation tends to underestimate the dose in the high does region and to a lesser extent overestimate in the low dose range under specific software circumstances.
Retiro De Equipo (Recall) de ALARIS SYSTEM - PUMP
  • Tipo de evento
    Recall
  • ID del evento
    23512
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2014-04-24
  • 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
    Software problem causing 'delay until' and 'multidose' feature to malfunction and starting infusion earlier or later than intended.
Retiro De Equipo (Recall) de LIQUICHEK DIABETES CONTROL
  • Tipo de evento
    Recall
  • ID del evento
    23513
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-03-03
  • 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
    Bio-rad laboratories canada ltd emet ce rappel en reponse a la demande du fabricant qui a remarque que les valeurs de l'hemoglobine a1c peuvent diminuer progressivement pendant la duree de vie du produit. bio-rad a revise les fiches de donnees du liquichek diabetes control pour l'hemoglobine a1c dans la section limites. toutes les autres valeurs d'analyte pour ces lots de liquichek diabetes control restent inchangees.
Retiro De Equipo (Recall) de POLYSTAR SYSTEM 1 FLUOROSCOPY/RADIOGRAPHY SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    23515
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    1996-06-28
  • 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
Retiro De Equipo (Recall) de LATEX POWDERED EXAMINATION GLOVES - SIZE FITTED
  • Tipo de evento
    Recall
  • ID del evento
    23523
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-05-26
  • 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
    Revised labelling related to corrective action at distributor level.
Retiro De Equipo (Recall) de HT50 VENTILATOR
  • Tipo de evento
    Recall
  • ID del evento
    23524
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2003-05-12
  • 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
    Ventilator stopped ventilatio without alarming. this condition could be due to build up of electrostatic in the device.
Retiro De Equipo (Recall) de KODAK RP X-OMAT DEVELOPER REPLENISHER
  • Tipo de evento
    Recall
  • ID del evento
    23525
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    1995-10-10
  • 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
Retiro De Equipo (Recall) de KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CHOL)
  • Tipo de evento
    Recall
  • ID del evento
    23542
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    1996-07-22
  • 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 INSTRUMENT MANAGER
  • Tipo de evento
    Recall
  • ID del evento
    23543
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-03-08
  • 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
    Importing error code mapping into instrument manager (im) v.8.12.10 and higher may clear another configuration's error code mapping. results that should be flagged from that configuration will not be flagged and have no result error codes. rules that evaluate error code(s) may also be affected. per data innovations: the absence of result flags and error codes compromises result evaluation and handling. medical decisions based on these potentially erroneous results can lead to patient harm.
Retiro De Equipo (Recall) de HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR FOUR BRANCH GRAFT
  • Tipo de evento
    Recall
  • ID del evento
    23546
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2006-02-14
  • 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
  • Causa
    The reason for the recall is that the 10mm left branch (innominate/brachiocephalic) and the 8mm right branch (left subclavian) may be in reversed order relative to the product specification.
Retiro De Equipo (Recall) de AXIOM ARTIS FC
  • Tipo de evento
    Recall
  • ID del evento
    23547
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2004-07-28
  • 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
    Sw update (see main screen).
Retiro De Equipo (Recall) de AXIOM ARTIS FC
  • Tipo de evento
    Recall
  • ID del evento
    23551
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2003-04-11
  • 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
    Software patch and new motor controller hardware.
Retiro De Equipo (Recall) de COMPAT ENTERAL DELIVERY SETS
  • Tipo de evento
    Recall
  • ID del evento
    23552
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2011-11-30
  • 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
    Nestle health science determined that drip chamber material in select codes of compat enteral feeding administration sets produced prior to august 2009 may have caused slip-off occurrences.
Retiro De Equipo (Recall) de ASCENSION RADIAL HEAD IMPLANT
  • Tipo de evento
    Recall
  • ID del evento
    23557
  • Clase de Riesgo del Evento
    II
  • 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 MCP (MODIFIED CAPTURE-P) SOLID PHASE SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    23558
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2004-05-12
  • 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
    Modified capture-p kits were packaged with modified capture-r test wells. there are no product defects associated with modified capture-p kit other than the mis-packaging of the test wells.
Retiro De Equipo (Recall) de ULTRAVIEW 1700 MONITOR
  • Tipo de evento
    Recall
  • ID del evento
    23561
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2003-11-14
  • 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
  • Causa
    When the external power supply begins to fail it causes the audio (alarm tones) to fail before the display shows any symptoms of failure such as dimming or flickering.
Retiro De Equipo (Recall) de PRONTO-SHORT EXTRACTION CATHETER
  • Tipo de evento
    Recall
  • ID del evento
    23563
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-11-30
  • 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
    The exp. date of the sterile pouched guidewire was not considered when exp. dating was calculated for the finished device. cannot assure sterility or function of the guidewire beyond its exp date.
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