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  • Dispositivo 2
  • Fabricante 2
  • Evento 124969
  • Implante 0
Retiro De Equipo O Alerta De Seguridad para Radioscopic diagnostic systems "Optima XR200amx", "Op...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2016-02-08
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possibility of failure in the safety locking mechanism of the horizontal arm of the portable radiography systems "Optima XR200amx", "Optima XR220amx" and "Brivo XR285amx", manufactured by GE Healthcare, USA.
Retiro De Equipo O Alerta De Seguridad para CARESCAPE B850 monitor
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2012-09-11
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possible safety problems related to the "CARESCAPE B850 Monitor" product, manufactured by GE Healthcare Finland Oy, Finland, which could produce a constant restart and remote printing problems with the PRN50 recorder.
Retiro De Equipo O Alerta De Seguridad para Disposable temperature probe 9FR for general use, 400...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2013-11-29
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Risk of nosebleed when the general purpose 9FR disposable temperature probe, 400 series, Ref .: M1024229, manufactured by GE Healthcare Finland Oy, is inserted nasally.
Retiro De Equipo O Alerta De Seguridad para Monitors Carescape TM B850 and Carescape TM B650, wit...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2014-03-14
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possible safety problems associated with the CarescapeTM B850 and CarescapeTM B650 monitors, with software versions 2.02, manufactured by GE Healthcare Finland Oy, Finland.
Retiro De Equipo O Alerta De Seguridad para CARESCAPE B850 monitor with software versions 1.0.12....
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2014-03-21
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possible safety problems related to certain CARESCAPETM B850 and B650 Monitors, manufactured by GE Healthcare Finland Oy, Finland.
Retiro De Equipo O Alerta De Seguridad para • E-miniC single width breathing modules, serial numb...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2014-09-11
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Failure in the CO2 detector of the E-miniC single-width breathing module and the N-FC and M-FCREC extension modules, manufactured by GE Healthcare Finland Oy, Finland.
Retiro De Equipo O Alerta De Seguridad para Respiratory Modules "CARESCAPE E-sCO", "E-sCOV", "E-s...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2014-10-08
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possible failure in a component of the O2 sensor associated with the respiratory modules "CARESCAPE"; the "Airway Gas Option N-CAiO" system and its respective spare units, manufactured by GE Healthcare Finland Oy, Finland.
Retiro De Equipo O Alerta De Seguridad para "Versions 6.2; 6.2.1; 6.3 and 6.3.1 of the communicat...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2013-10-02
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possible inaccurate calculation of the pulsatility index for venous flow measurements in the "ViewPoint 6" system, manufactured by GE Healthcare GmbH, Germany.
Retiro De Equipo O Alerta De Seguridad para Radiological Systems "OEC 9800", "OEC UroView 2800", ...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2014-12-10
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Detection of several security problems due to the change of certain components of the "OEC 9800", "OEC UroView 2800", "OEC MiniView 6800" and "FlexiView 8800" systems, manufactured by GE Healthcare Surgery, USA.
Retiro De Equipo O Alerta De Seguridad para Proteus XR / a radiological systems with wall bracket...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2015-01-16
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possibility of bucky fall of the wall support of the Proteus XR / a radiological systems, manufactured by GE Hualun Medical Systems Co. Ltd, China, due to the breakage of the steel cables that support it
Retiro De Equipo O Alerta De Seguridad para Discovery XR656 digital radiographic system
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2014-09-25
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    : Possibility of falling of the FlashPad ™ wireless digital detector in certain Discovery XR656 wall systems, manufactured by GE Hualun Medical Systems Co. Ltd. China, due to the use of nylon support hooks that do not meet the specifications
Retiro De Equipo O Alerta De Seguridad para radiological systems Proteus XR / a
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2015-03-05
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Risk of breakage of the steel cable that holds the Buck in certain wall supports of the Proteus XR / a radiological systems, manufactured by GE Hualun Medical Systems Co.Lt, China.
Retiro De Equipo O Alerta De Seguridad para GE Brivo System OEC715, OEC785 and OEC865
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2013-10-28
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possibility of a loss of functionality of the Brivo system, manufactured by GE Hualun Medical Systems, Co. Ltd., China, due to a fault in the wires of the high voltage cable bundle.
Retiro De Equipo O Alerta De Seguridad para GE Brivo System OEC715, OEC785 and OEC865
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2016-10-24
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possibility of unsolicited movements of the C-arc in certain GE Brivo systems, OEC 715/785/865 models manufactured by GE Hualun Medical Systems, Co. Ltd., China. PRODUCTS
Retiro De Equipo O Alerta De Seguridad para Patient data module (PDM) Carescape
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2014-05-14
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possibility of an unexpected loss of the patient monitoring function with the Carescape Patient Data Module (PDM), manufactured by GE Medical Sys Inc., USA, due to an intermittent failure of the spring mounting latch
Retiro De Equipo O Alerta De Seguridad para Patient monitors Dash 3000, 4000 and 5000, software v...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2012-11-19
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possibility that the function of the personalized automatic non-invasive blood pressure measurement (NBP) cycle of the Dash 3000, 4000 and 5000 patient monitors, manufactured by GE Medical Systems, USA, will be unexpectedly deactivated
Retiro De Equipo O Alerta De Seguridad para Nuclear medicine systems
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2013-07-10
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Cessation of the use of certain nuclear medicine systems manufactured by GE Medical Systems Israel, Functional Imaging, Israel, due to the possibility that the fixings of the support mechanism may be loosened.
Retiro De Equipo O Alerta De Seguridad para Discovery MR450, Discoveri MR750 and Optima MR450w
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2013-10-07
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possible transmission of infectious agents between patients due to the exposure of the yellow foam of the rear bells of the MRI systems, Discovery MR450, Discoveri MR750 and Optima MR450w, manufactured by GE Medical Systems
Retiro De Equipo O Alerta De Seguridad para Nuclear medicine systems Helix, Infinia, Infinia Hawk...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2014-03-07
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possibility of an unexpected movement of the detector in the nuclear medicine systems Helix, Infinia and Infinia Hawkeye and in the systems Millennium VG, VG Hawkeye and VariCam, manufactured by GE Medical Systems, Israel.
Retiro De Equipo O Alerta De Seguridad para The nuclear medicine systems VG and VG Hawkeye, Infin...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2014-12-30
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Update of the program and the preventive maintenance procedure of certain nuclear medicine systems manufactured by GE Medical Systems Functional Imaging, Israel.
Retiro De Equipo O Alerta De Seguridad para Carescape B20 and B40 monitors
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2012-12-26
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possible failure of the lethal arrhythmia alarm in the NEONATAL mode in certain software versions of the Carescape B20 and B40 monitors, manufactured by GE Medical Systems Information Technologies Inc., USA.
Retiro De Equipo O Alerta De Seguridad para Patient Data Module of the patient monitoring system ...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2014-05-19
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possible accumulation of heat on the cover of the Patient Data Module of the patient monitoring system Solar 8000 M / i, manufactured by GE Medical Systems Information Technologies Inc., USA, due to the liquid entering the assembly of the patient.
Retiro De Equipo O Alerta De Seguridad para Monitors Solar 8000M / i
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2014-06-18
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Risk of failure of the Automatic Alarm Display (AVOA) function of the "Solar 8000M / i Monitors", manufactured by GE Medical Systems Information Technologies Inc., United States.
Retiro De Equipo O Alerta De Seguridad para "T2100 treadmill"
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2015-05-19
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possibility, that during the stress tests, there is an uncontrolled movement of the "T2100 treadmill", manufactured by GE Medical Systems Information Technologies Inc., USA.
Retiro De Equipo O Alerta De Seguridad para "Motorized tapes T2000 and T2100"
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2015-06-11
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possibility that the power cable of the "T2000 and T2100 motorized tapes", manufactured by GE Medical Systems Information Technologies Inc., USA, has been improperly mounted and an electric shock may occur
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Acerca de la base de datos

Explore más de 120,000 registros de retiros, alertas y notificaciones de seguridad de dispositivos médicos y sus conexiones con los fabricantes.

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