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Vista de la lista Vista de las tarjetas
  • Dispositivo 14
  • Fabricante 10
  • Evento 124969
  • Implante 0
Retiro De Equipo O Alerta De Seguridad para Reagents ACHITECT SHBG, references 8K26-20 and 8K26-25
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-04-26
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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
    Safety warnings regarding the use of sample tubes with potassium EDTA.
Retiro De Equipo O Alerta De Seguridad para Synchromed II implantable drug infusion pump, Model 8...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-04-28
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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
    Safety warnings: update of previous recommendations for the treatment of implanted patients.
Retiro De Equipo O Alerta De Seguridad para Olympus Duodenoscope TJF-145.
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-04-28
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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
    Safety warning: New reprocessing instructions.
Retiro De Equipo O Alerta De Seguridad para Spheres (strawberries) diamond with coarse and extra-...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-04-28
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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
    Withdrawn from the market due to the possible release of particles
Retiro De Equipo O Alerta De Seguridad para Header Monitors Life Scope G9 series, model CSM-1901
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-04-28
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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
    Security warning related to the automatic resume function
Retiro De Equipo O Alerta De Seguridad para Rechargeable Li-ion batteries used in Beneview T1 pat...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-05-03
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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
    Withdrawal from the market due to possible overheating of the battery
Retiro De Equipo O Alerta De Seguridad para Pulsante® sphenopalatine ganglion micro-stimulator sy...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-05-03
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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
    Withdrawal from the market due to inadequate validation of a component of the system.
Retiro De Equipo O Alerta De Seguridad para Femoral stems LINE
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-05-03
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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
    Safety warnings in relation to the admissible weight per patient
Retiro De Equipo O Alerta De Seguridad para Sensis systems (AXIOM Sensis)
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-05-04
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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
    Security warnings related to the failure to start the system
Retiro De Equipo O Alerta De Seguridad para Allura XperFD and Allura CV20 intervention systems wi...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-05-04
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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
    Safety warnings related to a problem in the detector's cooling system.
Retiro De Equipo O Alerta De Seguridad para Disposable devices for hyperthermic perfusion treatments
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-05-05
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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
    Additional recommendations related to the handling of the protective cap.
Retiro De Equipo O Alerta De Seguridad para ACOR® hip-strap of modular intention and modular neck...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-05-05
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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
    Safety warning related to the restrictions of certain combinations of modular necks and femoral heads.
Retiro De Equipo O Alerta De Seguridad para Syringe pumps AlarisTM GS, GH, CC, TIVA, PK, Enteral ...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-05-08
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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
    Safety warnings related to the spring of the pusher cover.
Retiro De Equipo O Alerta De Seguridad para ADVIA Centaur Insulin Calibrator and ADVIA Centaur In...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-05-08
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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 use due to a discrepancy with the international standard of the World Health Organization IRP 66/304
Retiro De Equipo O Alerta De Seguridad para EP-TRACER
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-05-08
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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
    Safety warnings related to auxiliary stimulation parameters
Retiro De Equipo O Alerta De Seguridad para Neuro Stereotactic System | mate® used with Voxim® so...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-05-08
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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
    Safety warnings related to the "Tranfer Plan" function
Retiro De Equipo O Alerta De Seguridad para Inflation system DOLPHIN
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-05-08
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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
    Safety warning related to a potential defect in the primary blister packaging that could compromise the sterility of the device
Retiro De Equipo O Alerta De Seguridad para Access BR Monitor Trial, reference 387620, used with ...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-05-09
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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
    Safety warnings in relation to obtaining results below the upper limit of reference
Retiro De Equipo O Alerta De Seguridad para ARROW® kits that include BD Eclipse ™ needles
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-05-09
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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
    Safety warning, related to the safety cover of the needle
Retiro De Equipo O Alerta De Seguridad para VITROS 250 and 350 Chemistry System with software ver...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-05-09
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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
    Security warning related to the new version 9.5 of the software
Retiro De Equipo O Alerta De Seguridad para Defibrillator / Monitor Efficia DFM100, model code 86...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-05-10
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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 use due to a defective component in the PCA circuit of the treatment plate
Retiro De Equipo O Alerta De Seguridad para LABScreen® Multi, Catalog ID LSMUTR
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-05-10
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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
    Safety warnings due to an error in revision 8 of the instructions for use.
Retiro De Equipo O Alerta De Seguridad para Stamey Needle, Clarke-Reich Laparoscopic Knot Pusher,...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-05-10
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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 use, because the information on the reprocessing contained in the instructions for use of these instruments is insufficient.
Retiro De Equipo O Alerta De Seguridad para Omega standard drive screw 110 mm in length, batch no...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-05-10
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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
    Withdrawal from the market due to manufacturing failure
Retiro De Equipo O Alerta De Seguridad para PAK needles (pedicle access kit). Model 8670009
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-05-11
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • 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
    Withdrawal from the market due to an error in the packaging process.
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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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