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  • Dispositivo 42
  • Fabricante 18
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de INTEGRIS BH5000 CARDIOLOGY IMAGING SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    24116
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-05-12
  • 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
    A partial grid-switch failure may occur in allura xper and integris systems that may result in a higher x-ray dose than expected. this issue may pose a risk for patients or users. the potential failure can lead to a radiation exposure rate in excess of the 11.5 r/min health canada requirement. however it will only occur if the grid switch fails during fluoroscopy examinations using high kv values.
Retiro De Equipo (Recall) de NANOCLAVE EXT SET
  • Tipo de evento
    Recall
  • ID del evento
    24118
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-12-27
  • 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
    Certain lots of the nanoclave needlefree connector product line have a potential for leakage and subsequent blood loss by a pedriatic patient.
Retiro De Equipo (Recall) de HEALING SCREW SPLINE
  • Tipo de evento
    Recall
  • ID del evento
    24137
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    1999-11-17
  • 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
    Mislabelled packaged trays. trays with 13mm splines labelled as 15mm and trays with 15 mm splines labelled as 13 mm.
Retiro De Equipo (Recall) de ICONOS R200 FLUOROSCOPIC XRAY STEM
  • Tipo de evento
    Recall
  • ID del evento
    24138
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2003-08-12
  • 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
    Sw upadte vc10a to vc10b.
Retiro De Equipo (Recall) de CELL-DYN 3200SL SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    24139
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2004-03-11
  • 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 wants to clarify conditions that will generate a blast flag and use of dispersional data alerts with regard to platelet clumping.
Retiro De Equipo (Recall) de BD DIFCO CENTRIMEDE AGAR BASE
  • Tipo de evento
    Recall
  • ID del evento
    24140
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2004-06-14
  • 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
  • Causa
    Same as menu 8 - field 14.
Retiro De Equipo (Recall) de MEVATRON LINEAR ACCELERATORS
  • Tipo de evento
    Recall
  • ID del evento
    24141
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2007-09-14
  • 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
    Inform users that a misplacement of the x and/or y jaws can occur if interlock#51 jaw field position is asserted and then cleared with the left-hand key reset. this action can lead to an incorrect field size.
Retiro De Equipo (Recall) de LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT - LEVEL 3
  • Tipo de evento
    Recall
  • ID del evento
    24149
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2008-04-04
  • 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
    Bio-rad has observed that the performance of the above mentioned lots could be affected : troponine t does not meet the 5 day open vial claim. troponine t may gradually decrease over the product shelf life.
Retiro De Equipo (Recall) de HINTEGRA TALAR CUTTING GUIDE
  • Tipo de evento
    Recall
  • ID del evento
    24150
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-10-20
  • 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
    New deal sa has recently become aware that hintegra talar cutting guides used for talus resection during hintegra total ankle prosthesis have an inadequate specification. the width of those affected products is too large.
Retiro De Equipo (Recall) de PROCLEAR 1-DAY
  • Tipo de evento
    Recall
  • ID del evento
    24152
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-11-18
  • 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
    One hundred ninety-eight (198) total units have incorrect expiration date on the secondary packaging (outer carton). the primary lens packages (blisters) contained in these units are not affected and retain the original and correct expiration date.
Retiro De Equipo (Recall) de JULIAN ANESTHESIA WORKSTATION
  • Tipo de evento
    Recall
  • ID del evento
    24155
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    1999-10-20
  • 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
    Under certain conditions oxygen can contaminate the air supply line and/or air can contaminate the oxygen line if the valve used to select oxygen or air becomes stopped in the middle position.
Retiro De Equipo (Recall) de ALARIS SYSTEM - PUMP
  • Tipo de evento
    Recall
  • ID del evento
    24163
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-06-09
  • 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
    The user can reproduce a free-flow condition if the clinician does not close the roller clamp on the iv administration set prior to opening the pump door and the pump door is opened by using a "flick" of the door latch that causes the door to "pop" open instead of opening the door by slowly raising the latch. this flicking motion may cause the centered sear design to not effectively engage with the safety clamp fitment which can cause unintended flow possibly resulting in an over infusion to the patient.
Retiro De Equipo (Recall) de FRENCH COLLEAGUE 3 CXE VOLUMETRIC PUMP
  • Tipo de evento
    Recall
  • ID del evento
    24164
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-07-17
  • 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
    Baxter corporation is issuing this communication for the colleague volumetric infusion pump vp1.7a regarding difficulty removing an iv administration set from a pump after administration has been completed.
Retiro De Equipo (Recall) de MONOPOLAR CORD
  • Tipo de evento
    Recall
  • ID del evento
    24171
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-01-04
  • 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
    Stryker has become aware that the testing from the supplier was missing/inadequate and as a result the units have the potential to fail sterilization validation testing and cleaning validation testing.
Retiro De Equipo (Recall) de MPS ACUTE CARE BED
  • Tipo de evento
    Recall
  • ID del evento
    24174
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2002-02-28
  • 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
    Peut affichi une valeur erronee du poid du patient & le "bed system exit" pourrait ne pas fonctionni.
Retiro De Equipo (Recall) de ICONOS R200 FLUOROSCOPIC XRAY STEM
  • Tipo de evento
    Recall
  • ID del evento
    24177
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2003-08-14
  • 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
    Software update vd10c.
Retiro De Equipo (Recall) de EXTERNAL DENTAL IMPLANT SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    24179
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2007-04-25
  • 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
    The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.
Retiro De Equipo (Recall) de POLYDOROS SX80
  • Tipo de evento
    Recall
  • ID del evento
    24209
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2002-07-30
  • 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
    To send out an advisory letter to our customers informing them of the possibility of sporadic loss of image data.
Retiro De Equipo (Recall) de ACCESS SYSTEM - TOTAL T4 ASSAY
  • Tipo de evento
    Recall
  • ID del evento
    24181
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-04-13
  • 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
    During an internal study some patient samples with total t4 concentrations above the measuring range of the access total t4 assay when diluted according to the access total t4 product instructions for use using one volume of sample with an equal volume of access total t4 calibrator s0 (zero) were falsely elevated up to 22%.
Retiro De Equipo (Recall) de LIQUICHEK CARDIAC MARKERS CONTROL LT LEVELS 1 2 3
  • Tipo de evento
    Recall
  • ID del evento
    24186
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2006-12-01
  • 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 ne publie plus de valeurs cibles et ne garantie plus la stabilite de l'homecysteine pour ces lots.
Retiro De Equipo (Recall) de VECTRA SYSTEM - TI PLATE FOUR LEVEL
  • Tipo de evento
    Recall
  • ID del evento
    24187
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-09-04
  • 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
    The elgiloy_clips are potentially missing from the ti vectra plate resulting in the inability to lock the screw onto the plates. the affected device may be missing all eight (8) clips from the screw holes. vectra plating systems include several options that have integral elgiloy clips. the purpose of the clips is twofold: to hold the drill guide in place during the site preparation and to lock the screws into the implant to assist with stability and help prevent screw back-out.
Retiro De Equipo (Recall) de ELECTROSURGICAL ELECTRODES DISPOSABLE
  • Tipo de evento
    Recall
  • ID del evento
    24190
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-10-13
  • 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
    The recall was initiated due to recent tests that indicated some midas touch needle electrodes with modified tip might have an insulation breach and could generate a risk of superficial burn to the patient and/or end-user.
Retiro De Equipo (Recall) de THOPAZ THORAXDRAINAGE SYSTEM - DOCKING STATION
  • Tipo de evento
    Recall
  • ID del evento
    24191
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-03-12
  • 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
    Non-compliance of cleaning guidelines as stated in the instruction for use.
Retiro De Equipo (Recall) de ASSURANCE TM 2000 HEART/ RESPIRATION MONITOR
  • Tipo de evento
    Recall
  • ID del evento
    24194
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    1998-10-08
  • 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
    Device may malfunction in a manner resulting in no alarm when one is expected.
Retiro De Equipo (Recall) de GALILEO ECHO INSTRUMENT
  • Tipo de evento
    Recall
  • ID del evento
    24198
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-05-09
  • 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
    Immucor was notified by biotek instruments inc. that the power supply that was part of a galileo instrument being tested for compliance with present standards for immunity and emission failed the radiated emissions test (en 55011:2007 + a2: 2007).
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