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  • Dispositivo 25
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  • Evento 124969
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Retiro De Equipo O Alerta De Seguridad para Multirall ™ 200 (3130001) and car S65 (3136011).
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-12-20
  • 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 proper coupling of the Multirall ™ 200 to the S65 car.
Retiro De Equipo O Alerta De Seguridad para Flow cytometry system AQUIOS CL, NP B30166
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-12-20
  • 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 erroneous results being generated by not correctly identifying the samples.
Retiro De Equipo O Alerta De Seguridad para Artis systems used with an Artis table.
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-12-20
  • 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 adjustment of the retaining ring that secures the bolt that secures the Artis trolley to the base of the table. If the retaining ring is missing or incorrectly installed, the bolt could come out of its base and the carriage board would slide to the ground so the operator or patient could be damaged.
Retiro De Equipo O Alerta De Seguridad para Rechargeable lithium-ion batteries with SKU: 10086042...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-12-21
  • 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 possibility that the rechargeable lithium batteries are not fully charged because they have the wrong firmware, which could limit the total operating time of the ventilator when it is not connected to the AC power supply.
Retiro De Equipo O Alerta De Seguridad para Dental implants Tapered Screw-Vent, references TSVTB1...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-12-21
  • 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
    Withdrawal from the market as it was detected that the two batches were inadvertently mixed during the manufacturing process, in such a way that the product contained in the packaging could not correspond to the product indicated on the label.
Retiro De Equipo O Alerta De Seguridad para Conventional Hemodialysis Lines (HD)
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-12-21
  • 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
    Removal from the market of certain codes and batches of conventional HD lines, due to the possible rupture of the pre-dialyzer arterial expansion chamber that can lead to a serious loss of blood if it is not detected.
Retiro De Equipo O Alerta De Seguridad para Better Care Net Server software used with the Dräger ...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-12-21
  • 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 warnings because versions of the "Net Server" network server software prior to 1.1.1.1021 that are used with the Dräger Infinity MView patient monitoring solution may show incorrect correspondence between the bed tags and the data of the parameters.
Retiro De Equipo O Alerta De Seguridad para BD Vacutainer® C & S urine tube with preservative. Ca...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-12-21
  • 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 use and withdrawal from the market of Lot 7256786, due to the fact that it does not comply with the Guarantee of the Level of Safety in Sterility (SAL), indicated in the technical data sheet of 10-6.
Retiro De Equipo O Alerta De Seguridad para Norm-Ject tuberkulin syringe, reference K-ATS-1000.
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-12-22
  • 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 of the indicated lots from the market because they were distributed without being subjected to the Lymulus Amebocyte Lysate Assays (LAL) and the Mouse Embryo Trials (MEA).
Retiro De Equipo O Alerta De Seguridad para Contact lenses 1-DAY ACUVUE® MOIST
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-12-22
  • 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 2840420107 due to the possible discoloration of the lens and the presence of small particles in the blister pack of the contact lens.
Retiro De Equipo O Alerta De Seguridad para Modular Distal Scrap Curve REVITAN®
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-12-22
  • 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
    Removal from the market of certain references and batches of the REVITAN® Distal Modular Curve because these instruments could be broken intraoperatively after prolonged use.
Retiro De Equipo O Alerta De Seguridad para Elecsys BRAHMS PCT
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-12-26
  • 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
    Cessation of the use of batches 16642301 and 20408401 of the Elecsys BRAHMS PCT test in the cobas e 801 modules due to the possibility of obtaining falsely low procalcitonin results compared to the results obtained in the cobas e 411 / MODULAR ANALYTICS E170 analyzers and in the cobas e 601 and 602 modules.
Retiro De Equipo O Alerta De Seguridad para Reduced energy defibrillation electrodes for children...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-12-26
  • 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
    Removal from the market of certain batches of defibrillation electrodes because the pictograms on the electrode package show an incorrect location of the electrodes on the infant, which can lead to the failure of defibrillation and serious injuries or death.
Retiro De Equipo O Alerta De Seguridad para Reagents ARCHITECT DHEA-S, references 8K27-20 and 8K2...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-12-26
  • 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
    - Cessation of use of certain references and lots of the ARCHITECT DHEA-S trial with samples of children up to 60 days of age, due to the possibility of obtaining falsely high results. - Safety warning that representative values ​​should not be used for samples of children up to 10 years of age, which are shown in the section "Expected values" in the instructions for using the ARCHITECT DHEA-S test.
Retiro De Equipo O Alerta De Seguridad para VITEK®2 AST Gram-Positive cards containing the Cefoxi...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-12-26
  • 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 because the limitation of Cefoxitim Screen (oxsf01n) "test by alternative method" for Staphylococcus pseudintermedius does not appear in the software and in some technical specifications.
Retiro De Equipo O Alerta De Seguridad para ARCHITECT c4000 Cuvette Segment (cuvette segment), re...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-12-27
  • 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 base of the segment of the ARCHITECT buckets will detach, which could lead to the generation of falsely diminished patient results.
Retiro De Equipo O Alerta De Seguridad para Digital linear accelerator with detector XVI and iVie...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-12-27
  • 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 arm of the detector extends uncontrolled due to gravity, and can cause serious injuries by collision with the patient.
Retiro De Equipo O Alerta De Seguridad para ETEST Teicoplanin 256 (TP) SPB and Foam presentation,...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-12-27
  • 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 underestimation of MIC values ​​of at least 1 dilution for Coagulase Negative Staphylococcus (CoNS). This underestimation would lead to a risk of false sensitive results of Teicoplanin linked in particular to the lack of an intermediate category interpretation, if EUCAST cut-off points are applied.
Retiro De Equipo O Alerta De Seguridad para Phadia Prime software up to version 2.1.4 included, w...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-12-27
  • 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 erroneous results can be generated by a Phadia Prime software problem up to version 2.1.4 when certain conditions occur with the Phadia 250, Phadia 2500E / EE and Phadia 5000E / E + E instruments when performing the EliA tests .
Retiro De Equipo O Alerta De Seguridad para Urine analyzer Atellica UAS 800, Reference 11065004
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-12-28
  • 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 because when the user selects the category to report additional particles without performing a manual result entry for this additional category, a result of zero "0" or negative "-" will be reported.
Retiro De Equipo O Alerta De Seguridad para Tests INMULITE®, INMULITE® 1000, INMULITE® 2000, INMU...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-01-03
  • 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 due to the possibility of interferences by biotin in certain INMULITE tests, which could bias the results of them.
Retiro De Equipo O Alerta De Seguridad para Pacemakers (TRC-P) and defibrillators (TRC-D) for car...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-01-03
  • 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 warning related to the possibility that the programming of a certain combination of parameters may cause the implanted device to revert to the permanent Safety Core® state and it is necessary to replace it.
Retiro De Equipo O Alerta De Seguridad para Pacemakers, pacemaker and cardiac resynchronization s...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-01-03
  • 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 warning related to an intermittent oversensing of the ventilation-minute sensor (MV) signal that can cause presyncope or syncope due to periods of stimulation inhibition.
Retiro De Equipo O Alerta De Seguridad para CELL-DYN Emerald 22 analyzer, reference 09H59-01
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-01-04
  • 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 warning because in the Levey-Jennings (LJ) printed graphs, the differential parameters of the WBC subpopulations (WBC count) do not match the LJ graphs available on the screen.
Retiro De Equipo O Alerta De Seguridad para Access catheter and SpyScopeTM DS introducer
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2018-01-04
  • 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
    Removal from the market of certain batches of the SpyScope DS catheter, due to the possibility that the cover of the working channel protrudes from the head of the chamber located in the distal tip of the catheter, being able to cause damage to the surrounding tissues during the procedure.
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