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  • Dispositivo 12
  • Fabricante 10
  • Evento 124969
  • Implante 5
Retiro De Equipo O Alerta De Seguridad para Allura Xper Systems, Allura Clarity, Allura CV, Allur...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-12
  • 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
    Inclusion of 5 additional configurations among cardiovascular intervention systems affected by the possibility of error in the interpretation of a fixed image as a live image (fluoroscopy).
Retiro De Equipo O Alerta De Seguridad para Syngo Workflow MLR, all versions.
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-12
  • 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 possibility that reports created in Classic CLient with the function of copying and pasting from an external source that contain "section breaks" may be transferred incomplete to external systems, because the data of the predefined sections of The template is not saved in the Syngo Workflow MLR database, which could lead to an incorrect diagnosis.
Retiro De Equipo O Alerta De Seguridad para Invia Motion, reference 087.4022 and 087.4024.
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-13
  • 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 possibility that the device stops recognizing the presence of the battery if the user repeatedly connects and disconnects the vacuum cleaner to the electric current with the battery fully charged.
Retiro De Equipo O Alerta De Seguridad para Bag with hemodialysis concentrate, reference SAK-304,...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-15
  • 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 batch 70879105 of the bags with hemodialysis concentrate, reference SAK-304, because it exceeds the endotoxin levels of 0.5 EU / ml established in the quality standard EN ISO 11663 "Dialysis fluid quality for hemodialysis and related therapies. "
Retiro De Equipo O Alerta De Seguridad para Flex® Calcium Reagent Cartridge for the Dimension Vis...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-15
  • 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 of lot 17171D because erroneously low results could be obtained.
Retiro De Equipo O Alerta De Seguridad para Cortisol Saliva ELISA, code RE52611
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-15
  • 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 of batches ECO142 and ECO143 due to the possibility of obtaining erroneously high cortisol values ​​in patients.
Retiro De Equipo O Alerta De Seguridad para Aurinio operating room luminaires of the L 110, L 120...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-15
  • 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 possible formation of cracks in the lamp holder with the consequent risk of breakage and installation of a mechanical safety element around the affected component.
Retiro De Equipo O Alerta De Seguridad para Suction hoses for XO 4 and XO FLEX Dental Units
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-15
  • 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 due to the possibility that the magnetic field generated by the magnet located inside the nozzle of the suction hose may interfere with the operation of pacemakers and defibrillators of implanted patients.
Retiro De Equipo O Alerta De Seguridad para OASIS.
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-15
  • 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 because operators could injure their fingers by touching the edge of the stainless steel strap located under the stretcher.
Retiro De Equipo O Alerta De Seguridad para RayStation 4.9 (RayPlan 1), RayStation 5, RayStation ...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-15
  • 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 a problem with the Center Beam in Faithful (CBF) function so that when more than one beam is defined in the same isocenter, CBF affects all beams in a way that may be unpredictable to the user and cause an error in the treatment if the resulting fields are not reviewed and approved.
Retiro De Equipo O Alerta De Seguridad para Flow cytometry system AQUIOS CL, NP B30166
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-15
  • 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 because, if a certain sequence of events occurs, the samples can be incorrectly identified, generating erroneous results for the patients.
Retiro De Equipo O Alerta De Seguridad para Intraoperative image system O-arm® 1000 (3rd edition)...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-15
  • 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 due to the detection of certain problems that may lead to the interruption of the surgery or to an unused radiological dose, so the company will proceed to update the software to version 3.2.1.
Retiro De Equipo O Alerta De Seguridad para ProGrade systems
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-15
  • 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 due to the possibility that the image is not transferred from the Skyplate wireless portable detector to the system, when the WIFI connection is weak.
Retiro De Equipo O Alerta De Seguridad para Ultrasonic diagnostic systems, references 1016200xx, ...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-15
  • 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 possible overheating of the head of certain probes when the ElaXto mode (sonoelastography application) is activated
Retiro De Equipo O Alerta De Seguridad para PA023E probe used in MyLab Ultrasound Diagnostic Systems
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-15
  • 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 that the PA023E probe power monitoring settings may not be suitable, under certain operating conditions, when connected to certain MyLab ultrasound systems, which could lead to heating of the probe head .
Retiro De Equipo O Alerta De Seguridad para CADD ™ medication reservoir cassettes (no flow interr...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-16
  • 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
    Extension of the market recall to new batches of CADD® 50 and 100 ml medication reservoir cassettes without flow interruption, with codes 21-7001-24, 21-7002-24 and 21-7100-24, because they can have been manufactured with a wrong pressure plate.
Retiro De Equipo O Alerta De Seguridad para Thermo Scientific ™ Oxoid ™ BIGGY Agar 500g CM0589B c...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-19
  • 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 the use of certain batches of the Thermo Scientific ™ Oxoid ™ BIGGY Agar 500g culture medium, because it does not meet the specifications.
Retiro De Equipo O Alerta De Seguridad para Patient positioning system ExacTrac
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-21
  • 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
    Safety warnings and additional instructions regarding the authorization of the beam by ExacTrac by means of procedures with Auxiliary Device Interface (ADI) and Varina's Clinac or Variable TrueBeam equipment, as they differ from the specifications recommended in the system user manual. ExacTrac patient positioning, and be able to cause a misinterpretation of the beam authorization through ADI.
Retiro De Equipo O Alerta De Seguridad para Carescape Central Station (CSCS2), all-in-one models ...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-21
  • 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
    Security warning due to the possibility of an unexpected failure in the screen processor, after starting or restarting the system which prevents the user from seeing the monitored data on the screen.
Retiro De Equipo O Alerta De Seguridad para DEA HeartStart FR3 and Monitors / External HeartStart...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-21
  • 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
    Safety warning related to the update of the instructions for the use of defibrillators in the section related to the placement of the adhesive electrode in the RCP meter.
Retiro De Equipo O Alerta De Seguridad para Dornier Gemini
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-21
  • 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
    Safety warnings due to the possibility that the intensity level of the shock wave application will increase accidentally during the treatment in "kV Change on the fly" mode
Retiro De Equipo O Alerta De Seguridad para Bio-Cal Heat Exchanger, Model 370 and 370I
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-21
  • 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
    Cessation of the use and removal of the BIO-CAL, Models 370 and 370I Heat Exchangers (heater-Cooler), due to the possibility of bacteria proliferating in water systems that can be transmitted to patients during surgery.
Retiro De Equipo O Alerta De Seguridad para Means for In Vitro Fertilization (IVF)
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-21
  • 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
    Safety warnings because certain references and batches of these media that use gentamicin contain high amounts of histamine.
Retiro De Equipo O Alerta De Seguridad para LIFEPAK 20e monitors / defibrillators, manufactured b...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-21
  • 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
    Safety warnings due to the possibility that some devices present failures that prolong the sudden interruption of the power supply, the blocking of the device or errors in the on or off.
Retiro De Equipo O Alerta De Seguridad para LIVES and mini LIVES
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-02-21
  • 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
    Safety warnings due to the possibility of obstructions of the pump and displacement of the SPR® label with color code (DOT), which could generate erroneous results due to a decrease in the pipetted volume.
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