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  • Dispositivo 2
  • Fabricante 2
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de INTERSTIM II NEUROSTIMULATOR SYSTEM - IMPLANTABLE STIMULATOR
  • Tipo de evento
    Recall
  • ID del evento
    56054
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-01-12
  • 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
    As this is a sap recall this recall was not webposted. the issue relates to the description of the use of cycling in the instruction manuals.
Retiro De Equipo (Recall) de SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
  • Tipo de evento
    Recall
  • ID del evento
    56084
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-09-26
  • 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
    Baxter corporation is recalling one (1) sigma spectrum infusion pump with master drug library that was shipped with a component that does not meet standards for withstanding an electrostatic discharge in excess of 15 kilovolts. such exposure could cause the pump to stop unexpectedly with no audible alarm or visual display of the alarm status.
Retiro De Equipo (Recall) de ARCHITECT "I" SYSTEM - ANTI-HBS ASSAY
  • Tipo de evento
    Recall
  • ID del evento
    56086
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2003-04-10
  • 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
    Particulate matter in the microparticle component.
Retiro De Equipo (Recall) de X SYSTEMS SERUM BENZODIAZEPINE ASSAY
  • Tipo de evento
    Recall
  • ID del evento
    56099
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2001-07-06
  • 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
    Medium and/or high controls were manufactured at methadone concentrations below the target value.
Retiro De Equipo (Recall) de XN-10 MODULE
  • Tipo de evento
    Recall
  • ID del evento
    56100
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-06-25
  • 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
    Sysmex corporation japan (scj) discovered that some xn-series analyzers' reaction chamber heaters have a possibility of abnormal heating that can lead to wire disconnection and a scorched or burnt odour.
Retiro De Equipo (Recall) de CLINAC LINEAR ACCELERATOR
  • Tipo de evento
    Recall
  • ID del evento
    56101
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2006-09-01
  • 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
    Gantry drive chain may break during gantry motion allowing gantry to rotate without motor control which may collide with a person who does not move out of its path causing serious physical injury.
Retiro De Equipo (Recall) de CAPTURE-R READ ID EXTEND II
  • Tipo de evento
    Recall
  • ID del evento
    56130
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-01-15
  • 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
    Immucor has received reports of unexpected positive reactivity when testing donor n3512 with anti-v. the initial investigation into these reports has confirmed that donor n3512 is v+ when tested with additional sources of anti-v. donor n3512 will be labeled as v+ going forward.
Retiro De Equipo (Recall) de SYSTEM 1000 DIALYSATE DELIVERY SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    56139
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2001-11-12
  • 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
    Instrument can experience a spontaneous dialysate proportioning ratio change which can result in severe patient acid-base disturbances.
Retiro De Equipo (Recall) de TORQVUE DELIVERY SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    56173
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2006-10-26
  • 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
    To provide recommendations to prevent adverse event related to the occurence of complete heart block (chb). oversizing of the device may contribute to the risk of chb.
Retiro De Equipo (Recall) de GALILEO ECHO INSTRUMENT
  • Tipo de evento
    Recall
  • ID del evento
    56143
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-11-27
  • 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
    The instrument may generate a negative well interpretation for capture-r ready-screen or capture-r ready-id assays and subsequent visual interpretation of those reactions are weak positive or questionable (equivocal).
Retiro De Equipo (Recall) de TOOL STRIPPER W/BLD 18S AUTOCLAVABLE
  • Tipo de evento
    Recall
  • ID del evento
    56152
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-06-19
  • 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
    Validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use for the reusable stripper and cleaver accessories do not meet the new guidance on qualifying reusable products.
Retiro De Equipo (Recall) de AMIA AUTOMATED PD SET WITH CASSETTE (DISPOSABLE SET)
  • Tipo de evento
    Recall
  • ID del evento
    56153
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2017-09-06
  • 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
    Baxter corporation is issuing a product recall for certain lots of the amia automated peritoneal dialysis set with cassette in response to increased customer complaints received for missing red line patient slow flow solution slow flow and inadequate drain alerts. increased frequency of these alerts could lead to insufficient draining of waste solution which can be a contributing factor in fluid overload.
Retiro De Equipo (Recall) de DX-D 100 MOBILE X-RAY UNITS
  • Tipo de evento
    Recall
  • ID del evento
    56160
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-01-20
  • 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
    In case motorized movement is not possible the unit needs to be moved manually. the procedure how to switch to manual movement and the tool needed is mentioned in the user manual but clarification is now being provided.
Retiro De Equipo (Recall) de VITROS CHEMISTRY PRODUCTS SYSTEM - 350 ANALYZER
  • Tipo de evento
    Recall
  • ID del evento
    56164
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-04-28
  • 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 (ortho) has verified the potential for some vitros 250/350 systems to intermittently become unresponsive (i.E. screen freeze) after installing software version 9.5.
Retiro De Equipo (Recall) de BASSINET CART
  • Tipo de evento
    Recall
  • ID del evento
    56165
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-03-09
  • 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
    Stance healthcare has received notification that bassinet drawers are opening when the bassinet is being pushed around a corner. stance healthcare has evaluated the risk of this occurrence and determined that this could lead to tipping of the cart causing injury. in order to reduce any possible risk of injury the company has decided to perform corrections on the bassinets.
Retiro De Equipo (Recall) de MICROSTAAR IOL INJECTOR CARTRIDGES SFC-25 MTC-60
  • Tipo de evento
    Recall
  • ID del evento
    56166
  • 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
  • Causa
    See comments.
Retiro De Equipo (Recall) de SOMATOM PLUS 4 VOLUME ACCESS
  • Tipo de evento
    Recall
  • ID del evento
    56170
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2004-12-01
  • 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
    See main screen -- transfer of convolution kernels to irs.
Retiro De Equipo (Recall) de SYNERGY BALLOON DILATATION CATHETER (PTA)
  • Tipo de evento
    Recall
  • ID del evento
    56174
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2003-05-06
  • 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
    If these balloons were to be inflated to the incorrectly labeled rated burst pressure the balloon could burst causing serious vessel damage.
Retiro De Equipo (Recall) de MAGNETOM SP MRI
  • Tipo de evento
    Recall
  • ID del evento
    56175
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    1997-07-18
  • 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
Retiro De Equipo (Recall) de PURITAN BENNETT 980 SERIES VENTILATOR - VENTILATOR
  • Tipo de evento
    Recall
  • ID del evento
    56200
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-01-20
  • 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
    Covidien is issuing a voluntary field corrective action notice for two issues on all models of puritan bennett 980 ventilators. 1-graphical user interface unresposive to touch. 2-loss of primary ventilation under certain circumtances.
Retiro De Equipo (Recall) de DEVON BIRTHDAY KIT C-SECTION BASIC
  • Tipo de evento
    Recall
  • ID del evento
    56201
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2015-04-20
  • 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
    Covidien is voluntary recalling specific lots of the devon light gloves and specific sterile kits. this recall is being conducted due to the risk that devon light gloves of these lots could contain splits or holes that could result in an unintentional tranfer of microorganisms by the clinician from the light handle into the patient wound.
Retiro De Equipo (Recall) de TRIAGE DRUGS OF ABUSE &MTD
  • Tipo de evento
    Recall
  • ID del evento
    56202
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-02-21
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Lot 259403 of the test kit was found to produce unexpected positive barbiturate results.
Retiro De Equipo (Recall) de ID-MTS IMPACT PIPETTOR
  • Tipo de evento
    Recall
  • ID del evento
    56203
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2002-09-09
  • 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
    There is a possibility of motor system failure in this instrument characterized by out of specification volume delivery for th 50ul 25ul and 10ul volumes.
Retiro De Equipo (Recall) de DIMENSION VISTA SYSTEMS ALIQUOT PLATES
  • Tipo de evento
    Recall
  • ID del evento
    56204
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-10-30
  • 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
    Manufacturer has confirmed intermittent aliquot plate barcode failure to read errors causing the plate to be discarded. the error is generated when the aliquot plate is being loaded onboard the instrument or recalled from the aliquot elevator for an add-on test. if the aliquot plate cannot be read it is discarded into the waste. not all plates within a lot exhibit the failure. not all instruments experience failures with the same lot of aliquot plates.
Retiro De Equipo (Recall) de MDA SYSTEM - 180 INSTRUMENT - CLASS 2
  • Tipo de evento
    Recall
  • ID del evento
    56205
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2003-11-26
  • 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
    Mandatory instrument retrofit:complaint regarding probe movements when the mda instrument has been suspended and the shield is open due to dust accumulation on the shield sensor.
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