• Acerca de la base de datos
  • ¿Cómo usar la IMDD?
  • Descargar la data
  • Preguntas frecuentes
  • Créditos
Vista de la lista Vista de las tarjetas
  • Dispositivo 1
  • Fabricante 1
  • Evento 124969
  • Implante 0
Notificaciones De Seguridad De Campo acerca de Lipase OSR6x30, Urinezuur OSR6x98, HDL-cholesterol...
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-03
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/03/eckman-coulter-inc.-lipase-osr6x30
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    Laboratories must be aware, however, that there is a small chance that napqi in toxic concentrations may lead to incorrectly low results for lipase, uric acid, hdl cholesterol and enzymatic creatinine.
Notificaciones De Seguridad De Campo acerca de Capnostream™20 and Capnostream™20p Bedside Patient...
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-04
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/04/oridion-medical-1987-capnostream
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    This letter notifies you that medtronic is issuing a software update for capnostream ™ 20 and capnostream ™ 20p bed monitors for patients.
Notificaciones De Seguridad De Campo acerca de Single-Use, Colpo-Pneumo Occluder
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-04
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/04/coopersurgical-single-use-colpo-pneumo-occluder
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    Coopersurgical recalls this product because of the possibility that the sealing of the sterile bag may be affected, increasing the risk of infection.
Notificaciones De Seguridad De Campo acerca de CentriMag Motor, OUS
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-06
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/06/thoratec-switzerland-centrimag-motor
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    In this context, we would like to inform you that we have received notifications where damage to the cable between the motor and the console of the centrimag system leads to a malfunction of the active support provided by the device.
Notificaciones De Seguridad De Campo acerca de AR-400UBH-accuhouder
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-07
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/07/arthrex-inc-ar-400ubh-accuhouder
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    It is possible that the battery is not completely trapped in the battery holder, as a result of which liquids might end up in the holder or could leak out of the holder, .
Notificaciones De Seguridad De Campo acerca de OCS (Organ Care System) Heart, OCS Lung and OCS Li...
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-10
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/10/transmedics-fsca-2018-002---ocs-organ-care-system-heart-lung-and-liver-consoles
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    As part of our product quality monitoring process, we identified a potential issue with the ocs device that could affect proper operation. in particular, the ocs console may lose communication with the perfusion module if the ocs contact buttons are not cleaned and maintained properly per the provided instructions for use.
Notificaciones De Seguridad De Campo acerca de Cordis® POWERFLEX® PRO PTA (Percutaneous Translumi...
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-10
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/10/cordis-cordis20180906-ous---powerflex-pro-pta-dilatation-catheter
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    Cordis has determined that five lots of powerflex® pro pta dilatation catheters have not met an internal manufacturing specification for shaft burst strength, though it meets the label claim (18 atm).
Notificaciones De Seguridad De Campo acerca de LATITUDE™ Programmer model 3300
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-11
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/11/cardiac-pacemaker-latitude-programmer-model-3300
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    Boston scientific recalls all latitude ™ programmers model 3300 as the psa (pacing system analyzer) may have unintentional cross-chamber stimulation.
Notificaciones De Seguridad De Campo acerca de RVC Clinical Assistant
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-13
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/13/rvc-medical-it-rvc-clinical-assistant
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    In the abovementioned versions, an error occurs when a user uses the relevant function more often: .
Notificaciones De Seguridad De Campo acerca de Cardiale resynchronisatietherapie-pacemakers (VISI...
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-13
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/13/cardiac-pacemaker-cardiale-resynchronisatietherapie-pacemakers
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    Battery may be drained prematurely due to hydrogen.
Notificaciones De Seguridad De Campo acerca de Stryker Model 8001 Altrix
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-13
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/13/stryker-medical-stryker-model-8001-altrix
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond 0.5°c while in automatic mode.
Notificaciones De Seguridad De Campo acerca de Raucodrape Camera Drape 16x250
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-13
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/13/lohmann--rauscher-raucodrape-camera-drape
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    Due to feedback from the market, the raucodrape camera cover was checked and in some cases leakages (small holes) were detected.
Notificaciones De Seguridad De Campo acerca de Connex Spot Monitor
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-14
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/14/welch-allyn-connex-spot-monitor
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    Internal testing at welch allyn has indicated connex spot monitors with masimo spo2 do not meet the 3rd edition iec60601-1-2 standard testing for electral fast transients and bursts (eft) and radiated immunity (ri).
Notificaciones De Seguridad De Campo acerca de FlexLab, Accelerator a3600, Aptio Automation
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-14
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/14/inpeco-sa-automation
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    In het modules listed in table 1, the transport mechanism that moves the robot along the axes generates a magnetic field which may interfere with pacemaker functionality at close distances.
Notificaciones De Seguridad De Campo acerca de O-arm™ 1000 Imaging System
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-17
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/17/medtronic-o-arm-1000-imaging-system
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    The purpose of this letter is to inform you that medtronic is voluntarily conducting a field action for installing software (sw) version 3.1.7 on all 2nd edition o-arm ™ 1000 imaging systems (o-arm 1000).
Notificaciones De Seguridad De Campo acerca de Alere DDS®2 Test Kits
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-17
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/17/alere-toxicology-plc-alere-dds2-test-kit
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    This message contains essential information about a cross-reactivity change that is described in the alere dds®2 test kits manual (dds2-403, dds2-404, dds2-407 and dds2-412).
Notificaciones De Seguridad De Campo acerca de Pastorex Meningitis
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-17
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/17/bio-rad-pastorex-meningitis
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    Recent customer complaints concerning unusual high rates of positive agglutination with the r4 reagent, streptococcus.Pneumoniae latex, not confirmed by another technique raised our concern on the product.
Notificaciones De Seguridad De Campo acerca de Elecsys FT4 III
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-18
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/18/roche-diagnostics
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    We wish to inform you about a reduced biotin interference threshold for the recently launched elecsys® ft4 iii assays.
Notificaciones De Seguridad De Campo acerca de ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 pacema...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    600:41/01-007/18/05_62
  • Fecha
    2018-09-10
  • País del evento
    Singapore
  • Fuente del evento
    HSA
  • URL de la fuente del evento
    https://www.hsa.gov.sg/announcements
  • Notas / Alertas
    Data from Singapore is current through September 2018. All of the data comes from the Health Sciences Authority (HSA), 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 Singapore.
  • Notas adicionales en la data
    Boston Scientific Corporation
Notificaciones De Seguridad De Campo acerca de Inter-atrial Shunt Device (IASD) System II/ Corvia...
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-18
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/18/corvia-medical-inter-atrial-shunt-device-iasd-system-ii
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    Corvia medical has been informed that additional risks may be associated with the procedures for implanting the iasd in individuals who have one or more pacemaker leads in the right atrium.
Notificaciones De Seguridad De Campo acerca de Zenith Alpha™ Thoracale Endovasculaire prothese
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-03-22
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2017/03/22/field-safety-notice-cook---zenith-alpha%E2%84%A2-thoracale-endovasculaire-prothese
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    Through this safety notice we want to draw your attention to some aspects of the new version of the instructions for the zenith alpha ™ thoracic endovascular prosthesis. these revisions are very important when you are using the device for the treatment of blunt thoracic trauma with aortic injury (blunt thoracic aortic injury - btai).
Notificaciones De Seguridad De Campo acerca de RayStation
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-20
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/20/raysearch-raystation
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    When using robust optimization functions, the background dose may not be taken into account, although in some cases it is displayed in the user interface.
Notificaciones De Seguridad De Campo acerca de BridgeMaster medicalFetal Scalp Blood SamplingKits
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-20
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/20/bridgemaster-medical-medicalfetal-scalp-blood-samplingkits
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    This field safety notice has been issued to provide clarification of additional contraindications for the use of bridgemaster medical's fetal scalp blood sampling kit (fbs-ac) and fetal scalp blood sampling wands (fbs-w).
Notificaciones De Seguridad De Campo acerca de CrystalClear Plus RUSCH CARE CrystalClear (PVC) Tr...
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-21
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/21/teleflex-crystalclear-plus
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    Teleflex medical recalls the above products because the inner diameter (id) is outside the specified dimensional tolerance and does not comply with relevant iso standards.
Notificaciones De Seguridad De Campo acerca de DRILL BITS
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2018-09-24
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/09/24/orthofix-drill-bits
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    This showed that some production batches of drills, manufactured in a limited period in 2017/2018, perform below standard with respect to drills that were previously manufactured.
  • 1
  • 2
  • 3
  • …
  • Next ›
  • Last »

Acerca de la base de datos

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

  • Preguntas frecuentes
  • Acerca de la base de datos
  • Contáctenos
  • Créditos

Historias en su correo

¿Trabaja en la industria médica? ¿O tiene experiencia con algún dispositivo médico? Nuestra reportería no ha terminado. Queremos oír de usted.

¡Cuéntanos tu historia!

Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

Descargar la data

La International Medical Devices Database está bajo la licencia Open Database License y sus contenidos bajo la licencia Creative Commons Attribution-ShareAlike . Al usar esta data, siempre citar al International Consortium of Investigative Journalists. Puede descargar acá una copia de la base de datos.

Descargar todo (zipped)