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  • Dispositivo 2
  • Fabricante 2
  • Evento 124969
  • Implante 0
Notificaciones De Seguridad De Campo acerca de Empira NC RX and RX Empira
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2014-51285
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2014/Engangsprodukter--Empira-NC-RX-och-Empira-RX--Creganna-Tactx-Medical/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    2014-01-FSCA
  • Acción
    Information on the risk of use. Modification of the manual
Notificaciones De Seguridad De Campo acerca de Emprint percutaneous antenna with Thermosphere-tech
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2017-62807
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN20161/Engangsprodukter--Emprint-perkutan-antenn-med-Thermosphere-teknik--Covidien-LLC/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    FA781
  • Acción
    Products should be revoked.
Notificaciones De Seguridad De Campo acerca de Emprint percutaneous antenna with Thermosphere-tech
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2016-17181
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2016/Engangsprodukter--Emprint--Covidien-LLC/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    Emprint Percutaneous Antenna 02/16
  • Acción
    Products should be revoked.
Notificaciones De Seguridad De Campo acerca de EnCor biopsy Probes
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2011/89368
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2012/Engangsprodukter-kirurgi---EnCor-Biopsisonder--Bard-Peripheral-Vascular/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    FA2011-12
  • Acción
    Withdrawal of the products.
Notificaciones De Seguridad De Campo acerca de Encore 26 pressure gauge syringe in single package
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2017-48416
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN20161/Engangsprodukter--Encore-26-manometerspruta-i-singelforpackning---Boston-Scientific-Corporation/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    92115538-FA
  • Acción
    Products should be revoked.
Notificaciones De Seguridad De Campo acerca de Encore, Chorus and Sara Plus Res- and stand lifts
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2012/35197
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2012/Personlyftar--Encore-Chorus-och-Sara-Plus-Res-och-stallyftar--ArjoHuntleigh-AB/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    FSN003/2012/PHD
  • Acción
    Warning information. Instructions on use of the products.
Notificaciones De Seguridad De Campo acerca de End bracket Low associated with bed bracket REKO
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2012/26217
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2012/Sangar--Andfaste-Lag-tillhorande-Sangbygel-REKO--Swereco-Rehab-AB/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    2302012
  • Acción
    Withdrawal of the products.
Notificaciones De Seguridad De Campo acerca de Endo GIA Ultra Universal handle for stacking
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2015-100913
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2016/Engangsprodukter--Endo-GIA-Ultra-Universal-handtag-for-stapling--Covidien-LLC/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    EGIA Handles 11/15, V26172
  • Acción
    Products should be revoked.
Notificaciones De Seguridad De Campo acerca de Endo HD II videotelescope
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2015-95714
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2015/Medicinsk-elektriskmekanisk-utrustning--ENDOEYE-HD-II-videoteleskop--Olympus-Winter--Ibe-GmbH/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    QIL-148P-01
  • Acción
    Products should be revoked. Modification of products.
Notificaciones De Seguridad De Campo acerca de Endo Linear Cutter Stapler
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2014-91633
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2014/Engangsprodukter--Endo-Linear-Cutter-Stapler--BJZHFPanther-Medical-Equipment-Co-Ltd/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    1
  • Acción
    Products should be revoked.
Notificaciones De Seguridad De Campo acerca de endo Peanut
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2017-37902
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN20161/Engangsprodukter--Endo-Peanut--Covidien-llc/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    FA771
  • Acción
    Products should be revoked.
Notificaciones De Seguridad De Campo acerca de Endo-Model rotational and hinge knee system SL, cl...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2012/29236
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2012/Implantat-ortopedi--Endo-Modell-rotations--och-gangjarnsknaprotessystem-SL--Waldemar-Link/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    R-2012-02
  • Acción
    Withdrawal of the products.
Notificaciones De Seguridad De Campo acerca de Endobon Xenograft Granules
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2016-4127
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2016/Implantat--Endobon-Xenograft-Granules--Zimmer-Biomet-France/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    FR HHE 2015-03
  • Acción
    Products should be revoked.
Notificaciones De Seguridad De Campo acerca de ENDOLAN lubricant gel endoscope 200 ml
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2017-57857
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN20161/Engangsprodukter--ENDOLAN-smorjgel-for-endoskop-200-ml--Wolfgang-Meiners-Medizintechnik-GmbH/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
  • Acción
    Products should be revoked.
Notificaciones De Seguridad De Campo acerca de ENDOPATH ETS Compact Flex 45mm
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2011/60084
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2011/Instrument-kirurgi--ENDOPATH-ETS-Compact-Flex-45mm--Ethicon-Endo-Surgery/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    CTS45-2011-08
  • Acción
    Withdrawal of the products.
Notificaciones De Seguridad De Campo acerca de EndoReturn-arterial cannula
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2013-67738
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2013/Engangsprodukter--EndoReturn-artarkanyl--Edwards-Lifesciences-LLC/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    FCA -31
  • Acción
    Products should be revoked.
Notificaciones De Seguridad De Campo acerca de EndoWrist Instrument Hot Shear monopolar curved sc...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2013-44485
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2013/Medicinsk-elektriskmekanisk-utrustning--EndoWrist-Instrument-Hot-Shears-monopolara-bojda-saxar--Intuitive-Surgical-Inc/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    2955842-05-07-2013-005
  • Acción
    Information on the risk of use.
Notificaciones De Seguridad De Campo acerca de EndoWrist instruments and accessories for the da V...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2013-21142
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2013/Elektromekaniska-medicintekniska-produkter--EndoWrist-Instrument-och-tillbehor-for-da-Vinci-Surgical-Systems--Intuitive-Surgical-Inc/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    2955842-122112-006
  • Acción
    Modification of the manual.
Notificaciones De Seguridad De Campo acerca de EndoWrist One kärlförslutare
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2015-17032
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2015/Medicinsk-elektriskmekanisk-utrustning--EndoWrist-One-karlforslutare--Intuitive-Surgical-Inc/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    2955842-01-26-2015-002-C
  • Acción
    Information on the risk of use.
Notificaciones De Seguridad De Campo acerca de EndoWrist One kärlförslutare for Surgical System d...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2014-84645
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2014/Medicinsk-elektriskmekanisk-utrustning--EndoWrist-One-karlforslutare--Intuitive-Surgical-Inc/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    2955842-09172014-007-C
  • Acción
    Information on the risk of use. Modification of the software. Modification of the manual. Modification of labeling.
Notificaciones De Seguridad De Campo acerca de Endurant and Endurant II bifurcated stent graft sy...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2017-17342
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN20161/Implantat--Endurant-och-Endurant-II--Medtronic-Inc/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    FA758
  • Acción
    Products should be revoked.
Notificaciones De Seguridad De Campo acerca de enFlow IV fluid / blood warmers
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2012/1610
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2014/Medicinsk-elektriskmekanisk-utrustning--enFlow-IV-vatske-blodvarmare--Vital-Signs-Inc/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    FMI 35010
  • Acción
    Warning information. Modification of the manual.
Notificaciones De Seguridad De Campo acerca de EnFlow IV fluid heater model 100
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2012/1610
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2012/Blod-och-vatskevarmare--EnFlow-modell-100--Enginivity--Vital-Signs--GE-Healthcare/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    FMI 35010
  • Acción
    Warning information. New instructions. Instructions on use of the products. Modification of instructions.
Notificaciones De Seguridad De Campo acerca de Enflow liquid heater model 100
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2012/1610
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2012/Blod-och-vatskevarmare--EnFlow-modell-100--Enginivity--Vital-Signs--GE-Healthcare1/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    FMI 35010 och FMI 35012
  • Acción
    Instructions on use of the products. Updating the previously published information.
Notificaciones De Seguridad De Campo acerca de enGen Laboratory Automation System
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2015-29688
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2015/In-vitro-diagnostiska-produkter--enGen-Laboratory-Automation-System--Ortho-Clinical-Diagnostics-Inc/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    CL2015-072
  • Acción
    Information on the risk of use. Modification of the software.
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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.