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  • Dispositivo 26
  • Fabricante 14
  • Evento 124969
  • Implante 0
Retiro De Equipo O Alerta De Seguridad para Digital linear accelerators of the types ARTISE ™, ON...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-02-17
  • 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
    Correction of certain safety problems in the Digital Linear Accelerators of the types ARTISE ™, ONCOR ™ and PRIMUS ™, with serial number from 3094.
Retiro De Equipo O Alerta De Seguridad para Digital linear accelerators of the PRIMUS ™ and MEVAT...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-02-17
  • 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
    Correction of a security problem in the Digital Linear Accelerators of the PRIMUS ™ and MEVATRON ™ types, with serial number less than 3094, by means of a hardware update.
Retiro De Equipo O Alerta De Seguridad para Metal heads: Modular femoral heads (CoCr), Protasul® ...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-02-21
  • 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
    Warnings from the company Zimmer GmbH, Switzerland, about the risk of using metallic heads, in the revision surgery of the hip prosthesis after the breakage of ceramic components.
Retiro De Equipo O Alerta De Seguridad para Anaconda ™ ONE-LOK Release Systems Bifurcated Body an...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2013-11-14
  • 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
    Withdrawal from the market of certain references of the Anaconda ™ ONE-LOK Bifurcated Body and Anaconda ™ Bifurcated Body, manufactured by Vasculotek ltd., Great Britain, due to the possible fracture of the release wire.
Retiro De Equipo O Alerta De Seguridad para Inhalation systems AKITA JET and AKITA2 APIXNEB
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2015-09-17
  • 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 overheating of the power supply, reference FW7405M / 24, used with the inhalation systems AKITA JET and AKITA2 APIXNEB, manufactured by Vectura GmbH, Germany.
Retiro De Equipo O Alerta De Seguridad para Virtuoso software image measurement tool, versions 5....
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2016-01-12
  • 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
    Incorrect measurement of scanned images at 4x, 10x and 40x magnification with the Virtuoso software image measurement tool, v. 5.4 and 5.5, manufactured by Ventana Medical System, USA, which could cause an incorrect estimation of the clinical stage leading to an inadequate treatment.
Retiro De Equipo O Alerta De Seguridad para VERSATOR hand piece, code VR-0030.
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2016-09-22
  • 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
    Removal from the market of certain batches of the VERSATOR handpiece, code VR-0030, manufactured by Veol Medical Technologies Pvt. Ltd., India, because the piece could stop working during surgery.
Retiro De Equipo O Alerta De Seguridad para lot 1KR5K1618 of the diagnostic test RESIST-3 OKN K-set
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-02-24
  • 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
    Possibility of confusion in the interpretation of the result of lot 1KR5K1618 of the RESIST-3 OKN K-set diagnostic test, due to the presence of a slight displacement between the test lines of OXA-48 (O) and KPC (K) in the window central of reading.
Retiro De Equipo O Alerta De Seguridad para Compact air gas modules E-CO, E-VOC, E-COVX, E-CAiO, ...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2014-07-21
  • 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
    Failure of the gas sampling pump associated with certain serial numbers of the Compact Air Gas Modules E-CO, E-VOC, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX, manufactured by GE Healthcare Finland Oy, Finland.
Retiro De Equipo O Alerta De Seguridad para Secura Protective Cream Z10 78g, article number 59447...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-03-01
  • 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 of lot 626110 of the product Secura Protective Cream Z10 78g, because it has been distributed without having the necessary regulatory authorizations in Europe.
Retiro De Equipo O Alerta De Seguridad para Battery charger And rechargeable lithium-ion batteries
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2014-11-12
  • 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
    Withdrawal from the market of the battery chargers Novacell NV-LC02 and Vanson V-95, and rechargeable lithium-ion batteries, manufactured by Vision-Sciences Inc., USA, due to the possibility of overheating and combustion during recharging.
Retiro De Equipo O Alerta De Seguridad para Breathing circuits
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2014-11-11
  • 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 of occlusions in the flow of gas in the Respiration Circuits, manufactured by Vital Signs, USA, if the plugs are not removed from all ports of the circuit before using them.
Retiro De Equipo O Alerta De Seguridad para Volker beds
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2013-05-30
  • 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
    Possibility of a loss of electrical functionality in certain Volker beds, manufactured by Völker GmbH, Germany.
Retiro De Equipo O Alerta De Seguridad para medical beds and clinics Völker ™ 2080, 2082, S 280 a...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2016-04-07
  • 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
    Update of the instructions for the periodic technical inspection of Völker ™ 2080, 2082, S 280 and S 282 medical beds and clinics, manufactured by Völker GmbH, Germany, after having detected that after prolonged use, the glue between the side rail and the foot of the bed can be released
Retiro De Equipo O Alerta De Seguridad para Völker ™ beds, Models 2080, 2082, S 280 and S 282 wit...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2016-06-17
  • 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 the side rail of certain Volker beds manufactured by Völker GmbH, Germany, being lowered unintentionally and abruptly if the patient bends over it with all its weight.
Retiro De Equipo O Alerta De Seguridad para Mass spectrometers "ACQUITY®TQD, ACQUITY® SQD, LCT Pr...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2012-12-20
  • 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 heater failure of the source of the ionization block of the mass spectrometers "ACQUITY®TQD, ACQUITY® SQD, LCT PremierTM XE, Quattro PremierTM, Quattro PremierTM XE, QuattroTM micro, Xevo® G2 Tof, Xevo® TQ, Xevo ® TQD and ZQ2000 ",
Retiro De Equipo O Alerta De Seguridad para Non-rechargeable batteries, reference WM 40155, with ...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-02-24
  • 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 failure of the batteries, reference WM 40155, with serial number less than 20000, of the MEDUCORE Easy automatic external defibrillators, manufactured by Weinmann Emergency Medical Technology GmbH + Co.KG, Germany.
Retiro De Equipo O Alerta De Seguridad para Single-use patient tube systems of 2 m, used with the...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2016-05-18
  • 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
    Possibility that in the systems of tubes of the patient of a single use of 2 m, used with the respirators MEDUMAT Transport and MEDUMAT Standard2, manufactured by Weinmann Emergency Medical Technology GmbH, Germany, appear cracks in the area of ​​the connections of colored tubes Gray.
Retiro De Equipo O Alerta De Seguridad para Single-use patient tube systems of 2 m, used with the...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2016-06-27
  • 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
    Extension of the references of the systems of tubes of the patient of a single use of 2 m, used with the respirators MEDUMAT Transport and MEDUMAT Standard2, manufactured by Weinmann Emergency Medical Technology GmbH, Germany, affected by the possible appearance of cracks in the area of the hose connections are gray.
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