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  • Dispositivo 31
  • Fabricante 6
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de AQUILION 32 SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    78528
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2008-11-10
  • 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
    The actual scan start time may be delayed in surestart due to a software problem.
Retiro De Equipo (Recall) de ASPEN ULTRASOUND SYSTEM - PHYSIO MODULE
  • Tipo de evento
    Recall
  • ID del evento
    78545
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2002-07-03
  • 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
    To advise customers of an unlikely condition that may affect some transducers on the aspen/sequoia systems and to provide them with a list of affected transducers/mode combinations and workarounds.
Retiro De Equipo (Recall) de MICROLET - LANCETS
  • Tipo de evento
    Recall
  • ID del evento
    78546
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-01-06
  • 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
    A small quantity of lancet outer cartons labeled with europe ban 03856893 was incorrectly used in the production of lancet ban 81264997 for canada.
Retiro De Equipo (Recall) de SERVO-I VENTILATOR SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    78547
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-05-15
  • 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
    When using the servo-i on battery power some battery modules distributed after feb. 15 2010 have a shorter battery run time than expected. this could lead to an early power loss and a stoppage of ventilation.
Retiro De Equipo (Recall) de NAVIOS 8 COLORS / 2 LASERS
  • Tipo de evento
    Recall
  • ID del evento
    78549
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-10-24
  • 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
    Carousel barcode label does not match the dimensional specifications required by bec and that this condition may be a contributing factor to the mcl carousel failures related to the device.
Retiro De Equipo (Recall) de EPICENTER DATA MANAGEMENT SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    78550
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2005-02-07
  • 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
    Software defect was identified in the bd epicenter software v4.10a service release 2 and 3 (sr2 and sr3).If the rapid panel completion function is enabled there is a possibility of incorrect rapid results.
Retiro De Equipo (Recall) de ADVIA CHEMISTRY SYSTEM - PHENOBARBITAL_2 (PNHB_2) ASSAY
  • Tipo de evento
    Recall
  • ID del evento
    78551
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-11-19
  • 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
    Siemens healthcare diagnostics is conducting a recall for advia chemistry systems phenobarbital reagent lots 244574 and 256536. internal studies have indicated that these lots may exhibit increased imprecision and outliers.
Retiro De Equipo (Recall) de DIALOG+ DIALYSIS MACHINES - SINGLE PUMP
  • Tipo de evento
    Recall
  • ID del evento
    78554
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-11-18
  • 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
    Potential problem if servicing device and interchanging tubing between valve block level regulation and diaphragm pump if the functionality of the level regulation system is not tested as requested in the service manual. an interchanged tubing results in an inverse function of the manual level regulation system.
Retiro De Equipo (Recall) de AXIOM ARTIS FC
  • Tipo de evento
    Recall
  • ID del evento
    78917
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2004-08-25
  • 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
    See main screen - image issue.
Retiro De Equipo (Recall) de ATAKR II POWER GENERATOR ABLATION SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    78557
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2002-11-29
  • 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
    Manufacturer has received reports where manually increasing the temperature set point during rf energy delivery resulted in heart rhythm disturbances potential for induced ventricular fibrillation.
Retiro De Equipo (Recall) de FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
  • Tipo de evento
    Recall
  • ID del evento
    78594
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2008-10-28
  • 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
    Increase of problem code "cannot turn on" due to the retention force of cn601 being inadequate to hold front panel ribbon intact while pump is subject to bumping & jolting of normal shipment & use.
Retiro De Equipo (Recall) de VACUUM REGULATOR
  • Tipo de evento
    Recall
  • ID del evento
    78600
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    1997-10-20
  • 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
Retiro De Equipo (Recall) de VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYS. - DAT PERFORMANCE VER...
  • Tipo de evento
    Recall
  • ID del evento
    78604
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-09-21
  • 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
    Ortho clinical diagnostics has initiated this recall due to the potential to obtain lower than expected quality control (qc) results for vitros benz reagent using specific lots of vitros dat performance verifiers. if the issue occurs qc results for benz may be at or below ortho's range of means as defined in the assay sheets. this issue may lead to an inability to verify calibration or cause failures in daily qc results.
Retiro De Equipo (Recall) de VITROS 5600 INTEGRATED SYSTEM SOFTWARE
  • Tipo de evento
    Recall
  • ID del evento
    78605
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-07-28
  • 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
    Ortho-clinical diagnostics has identified two scenarios on the vitros 5600 integrated system (software version 1.4 and below) and vitros 3600 immunodiagnostic system (software version 1.4 and below) in which microwell and/or microtip reagent inventory may not be properly updated resulting in misidentified reagent packs and incorrect results or 'no result' being reported by the system.
Retiro De Equipo (Recall) de VITROS 5600 INTEGRATED SYSTEM SOFTWARE
  • Tipo de evento
    Recall
  • ID del evento
    78606
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-10-05
  • 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
    There have been rare occurrences where a microslide cartridge is misidentified after entering microslide cartridge lot information in the "manually load cart" dialogue. when this issue occurs it is possible for the vitros 5600 integrated system (software version 1.5 and below) and vitros 51 fs chemistry system (software version 2.5 and below) to process results from a cartridge other than the intended cartridge potentially leading to erroneous patient results.
Retiro De Equipo (Recall) de VERIFY CONTROL PLASMAS
  • Tipo de evento
    Recall
  • ID del evento
    78607
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2002-04-12
  • 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
    Aptt test was out of specification.The current stability testing of lot 111014 indicates that the reconstituted stability profile has exceeded our performance specification.
Retiro De Equipo (Recall) de CARELINK - MONITOR
  • Tipo de evento
    Recall
  • ID del evento
    78661
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-06-11
  • 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
    During an update a subset of carelink monitors of a previous design received firmware intended for monitors of a newer design. this mismatch makes affected monitors non-functional & unable to transmit data.
Retiro De Equipo (Recall) de SOMATOM FORCE
  • Tipo de evento
    Recall
  • ID del evento
    78704
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-04-12
  • 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
    An addendum to the instructions for use is being provided for somatom force systems with software version va50a to inform users about a potential malfunction for turbo flash scans with very short scan ranges. when selecting the turbo flash mode in combination with a spiral scan length of less than 27 mm the image reconstruction will possibly fail for this scan. as a work around the addendum suggests for the turbo flash mode to always select a spiral scan length higher than 27 mm or to switch to another mode instead.
Retiro De Equipo (Recall) de SHOCKPULSE LITHOTRIPSY GENERATOR
  • Tipo de evento
    Recall
  • ID del evento
    78712
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-12-01
  • 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
    Revised labeling- the rating label on the back of the ultrasonic generator specifies a voltage range of 100v to 240 v and based on tests this needs to be revised to 100v to 150 v.
Retiro De Equipo (Recall) de MOBILEDIAGNOST WDR
  • Tipo de evento
    Recall
  • ID del evento
    78716
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-06-21
  • 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
    Philips has become aware that under specific error conditions the system executes an unintended movement: 1)operator requests movement by presssing the dead man handle switch and pushing or pulling the handle bar.
Retiro De Equipo (Recall) de XCELA PICC WITH PASV VALVE TECHNOLOGY DOUBLE LUMEN IR KIT
  • Tipo de evento
    Recall
  • ID del evento
    78725
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-12-05
  • 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
    Potential for handles of included viapeel ptfe peelable introducer to detach from the sheath during use.
Retiro De Equipo (Recall) de HARMONY VLED SURGICAL LIGHTING SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    78728
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-12-15
  • 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
    Groups of steris harmanoy vled surgical lights (modules) contained within the vled light head may illuminate inconsistently. this issue is observed when the user attempts to adjust the lighting's display intensity via the lighting system's wall-mounted user interface panel.
Retiro De Equipo (Recall) de CALEO NEONATAL INCUBATOR
  • Tipo de evento
    Recall
  • ID del evento
    78729
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2002-09-10
  • 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
    Under certain extreme simultaneously present conditions there is a chance tha the actual t will deviate from the set temperature.
Retiro De Equipo (Recall) de MAXXUM HI-L0 BED
  • Tipo de evento
    Recall
  • ID del evento
    78730
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2007-12-19
  • 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
    A possibility of damage to the cotter ring on the ram end of the hi/lo motor may occur when the bed is in the low position during the use of patient lifts and/or cleaning areas of the bed and areas below bed.
Retiro De Equipo (Recall) de CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM - NEGATIVE CONTROL S...
  • Tipo de evento
    Recall
  • ID del evento
    78731
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-01-26
  • 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
    There is a potential issue when entering the clinitek atlas control lot information into the clinitek novus analyzer for the bottle lot numbers p0001105 p0003115 n0006115. this is due to a missing alpha character at the end of the lot number on the control bottles for example: lot p0001105 instead of p0001105x.
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