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  • Dispositivo 1
  • Fabricante 1
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de FRESENIUS 2008H HEMODIALYSIS MACHINE
  • Tipo de evento
    Recall
  • ID del evento
    109653
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    1996-06-11
  • 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
Retiro De Equipo (Recall) de DISETRONIC H-TRON PLUS INSULIN INFUSION PUMP
  • Tipo de evento
    Recall
  • ID del evento
    109658
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2001-03-14
  • 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
    Several incidents have been reported where the pump delivered an unknown amount of insulin when in a "wet environment".
Retiro De Equipo (Recall) de SYNCHRON SYSTEMS HEMOGLOBIN A1C (HBA1C) REAGENT
  • Tipo de evento
    Recall
  • ID del evento
    109661
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2003-07-22
  • 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
  • Causa
    The %hba1c resluts obtained using the reagent may be biazed low if the a1c result is greatere than the calibrator 4 value.
Retiro De Equipo (Recall) de T.E.S.S. - INSERT GLENOIDIEN
  • Tipo de evento
    Recall
  • ID del evento
    109687
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-02-16
  • 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
    Difficulty in insertion of anatomic insert pe (polyethylene) to cementless baseplate during surgery.
Retiro De Equipo (Recall) de INTRAOCULAR LENS MODEL P32UV
  • Tipo de evento
    Recall
  • ID del evento
    109722
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2001-06-22
  • 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
  • Causa
    The tyvek/mylar film pouch provides a sterile barrier is a two part laminate with an adhesive between a defect in the adhesive application process has allowed the layers to separate.
Retiro De Equipo (Recall) de PANEL ONE (11 CELL SUSPENSIONS)
  • Tipo de evento
    Recall
  • ID del evento
    109726
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2001-12-28
  • 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
    Phenotype of the cells in vial #7 (untreated) did not match the panel typing sheet. from house testing found return #7 cells had the same phenotype as the cells in vial#3. 1 complaint.
Retiro De Equipo (Recall) de RHEUMATOID FACTOR (RF) TEST
  • Tipo de evento
    Recall
  • ID del evento
    109728
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-04-26
  • 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 rheumatoid factor latex in the affected lots may give a rough negative reaction on some negative specimens.
Retiro De Equipo (Recall) de REMREST TIER 3 BAG POWER CORD AND TUBING
  • Tipo de evento
    Recall
  • ID del evento
    109735
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2005-02-21
  • 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
    Error in the product's firmware.
Retiro De Equipo (Recall) de FORMULA THERAPY DOMUS
  • Tipo de evento
    Recall
  • ID del evento
    109738
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2016-10-17
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    This voluntary field corrective action is being taken on the formula family of hemodialysis machines following reports of three thermal events which led to fire involving three different machines in the field. no patients or healthcare providers were injured as a result of these events. preliminary investigations indicate that the battery charge board was the source of two of the events. due to extensive damage on the machine the source of the third event is difficult to conclude. investigation into the trigger for the events is on-going. this recall involves all machines manufactured and imported since 1998. the corrective action will involve disconnection of the battery charge board to eliminate the possibility of the failure mode while a permanent solution is implemented.
Retiro De Equipo (Recall) de COULTER LH 500 HEMATOLOGY ANALYZER
  • Tipo de evento
    Recall
  • ID del evento
    109744
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2004-08-17
  • 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
    During the predilute mode the workstation may display transmit and/or print an erroneous result or an incorrect dilution factor with a predilute sample result.
Retiro De Equipo (Recall) de ULTRAVIEW CAPNOGRAPH MODULE
  • Tipo de evento
    Recall
  • ID del evento
    109772
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-05-20
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Spacelabs healthcare discovered during internal testing that the capnography module resets 20 seconds after power failure instead of after 3 minutes as specified. this reset clears the ram and the module returns to default settings.
Retiro De Equipo (Recall) de INVACARE PEDIATRIC FLOWMETER ACCESSORY
  • Tipo de evento
    Recall
  • ID del evento
    109777
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-06-23
  • 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
    The rear gradation scale was screen printed upside down on the flowmeter gauge. proper delivery of oxygen is critical to infants. in the population at greatest risk i.E. pediatric population health impact specific to high oxygen saturation could result in systemic toxicity potential lung vascular injury or over extended period of time could cause blindness.
Retiro De Equipo (Recall) de 1.5MM SCREW
  • Tipo de evento
    Recall
  • ID del evento
    109779
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2008-05-13
  • 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 packages may have contained the 1.5x4mm or ^1.5x3.5mm screws instead of the 1.5x5mm screws.
Retiro De Equipo (Recall) de SYNCHRON SYSTEMS CALIBRATOR 5 PLUS
  • Tipo de evento
    Recall
  • ID del evento
    109781
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2005-11-10
  • 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 set point for the rheumatoid factor has shifted and could increase both patient and qc values.
Retiro De Equipo (Recall) de STEALTHSTATION S7 - CART
  • Tipo de evento
    Recall
  • ID del evento
    109783
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-11-08
  • 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
    Some system control units (scu) mfr'd apr. - jul. 2010 have a defect that may result in the scu losing communication which may cause the optical tracking system to intermittently cycle or stop working.
Retiro De Equipo (Recall) de SAFETYGLIDE SYRINGE WITH SHIELDING INJECTION NEEDLE
  • Tipo de evento
    Recall
  • ID del evento
    109784
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-04-23
  • 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
    Complaints report that the 1ml safety glide needle disengages from the syringe after use. four scenarios have been reported: 1) the needle (cannula + hub) disengages after activating the safety feature (pop off) 2) the needle (cannula + hub) disengages from the syringe and remains on the patient's body after the procedure 3) the needle (cannula + hub) disengages when removing the needle cover 4) the needle (cannula + hub) disengages from the syringe and remains on the vial after drawing medication.
Retiro De Equipo (Recall) de ESSENTIAL NEO AN AUDIO/VISUAL INTEGRATION UNIT
  • Tipo de evento
    Recall
  • ID del evento
    109785
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-06-25
  • 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
    Power cable between essential neo unit and other audio/visual peripherals in the or could overheat and resulting in smoke and cessation of function of the peripheral device that the cable is connected to.
Retiro De Equipo (Recall) de ACCESS IMMUNOASSAY SYSTEM - ANALYZER CLASS 3
  • Tipo de evento
    Recall
  • ID del evento
    109792
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-09-29
  • 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
    Beckman coulter has determined that the access 2 console pc (b23083) may experience an "mfc exception" error during normal operation. if this error occurs the system will exit the access 2 user interface (ui) screen and display a window that notifies the user of a "0==itubescancount" event. if the ui is re-launched the system will prevent access to the sample manager screen to request samples for processing and the same "mfc exception" error will occur.
Retiro De Equipo (Recall) de NEWTON IQ DIALYSIS CYCLER SET
  • Tipo de evento
    Recall
  • ID del evento
    109795
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2006-04-20
  • 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
    Since 2006/03/07 fersenius medical care in the us has received 69 complaints which allege that patients could not thread/connect the stay safe patient connectors (trigger) to their pd transfer extension sets.
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