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  • Dispositivo 12
  • Fabricante 12
  • Evento 124969
  • Implante 0
Notificaciones De Seguridad De Campo acerca de Astral-fan
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2015-40107
  • 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/Anestesi--och-andningsstodjande-produkter--Astral-ventilator--ResMed-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
    CA0310
  • Acción
    Information on the risk of use. Modification of the software.
Notificaciones De Seguridad De Campo acerca de Asynja
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2012/18209
  • 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/Patientdatasystem--Asynja--CompuGroup-Medical-Sweden-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
    -
  • Acción
    Temporary measures. Follow-up of patients. Software upgrade.
Notificaciones De Seguridad De Campo acerca de Atellica Solution system with two or more Atellica...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2018-17202
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2018/In-vitro-diagnostiska-produkter--Atellica-Solution-system--Siemens-Healthcare-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
    ASW 18-01
  • Acción
    Information on the risk of use. Modification of the software.
Notificaciones De Seguridad De Campo acerca de ATLANTIS Abutment Titanium
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2015-59228
  • 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/Dentalprodukter--ATLANTIS-Abutment-Titanium--DENTSPLY-Implants-Healthcare-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
    S-PSC 2015-06-04
  • Acción
    Products should be taken out of service.
Notificaciones De Seguridad De Campo acerca de ATLANTIS, premiums and VERTEX adjustable drill stop
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2012/18581
  • 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/Instrument-ortopedi--ATLANTIS-PREMIER-och-VERTEX-stallbara-borrstopp--Medtronic-Sofamor-Danek/#
  • 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
    FA533
  • Acción
    Withdrawal of the products.
Notificaciones De Seguridad De Campo acerca de Atrium Ocean Oasis, Express and Express Mini drainage
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2016-94073
  • 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--Atrium-Ocean-Oasis-Express-och-Express-Mini-dranage--Atrium-Medical-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
    1219977-09-19-2016-001-C
  • Acción
    Information on the risk of use. Modification of labeling.
Notificaciones De Seguridad De Campo acerca de Atrium trocar catheter
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2016-82869
  • 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--Atruim-troakarkateter--Atrium-Medical-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
    1219977-19-09-2016-002-R
  • Acción
    Products should be revoked.
Notificaciones De Seguridad De Campo acerca de Attendant Control Co. pilot P + and R-net
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2012/88289
  • 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/Hjalpmedel-for-funktionshindrade--Vardarstyrning-Co-pilot-P-och-R-net--Permobil-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
    14543
  • Acción
    Information on the risk of use. Modification of labeling.
Notificaciones De Seguridad De Campo acerca de Attune INTUITIONTibial instruments tibia joint sur...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2015-52715
  • 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/Flergangsprodukter--ATTUNE-INTUITION--DePuy-Ireland-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
    103045639-QRB
  • Acción
    Information on the risk of use.
Notificaciones De Seguridad De Campo acerca de AU2700/AU2700 Plus & AU 5400 Clinical Chemistry An...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2012/7228
  • 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/IVD-produkter--AU2700AU2700-Plus-och-AU5400--Beckman-Coulter/#
  • 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
    EU-012012-001
  • Acción
    Instructions on use of the products. Modification of the instructions.
Notificaciones De Seguridad De Campo acerca de AU2700/AU2700 Plus Clinical Chemistry Analyzer ans...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2012/7228
  • 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/IVD-produkter--AU2700AU2700-Plus-Clinical-Chemistry-Analyzer-och-AU5400-Clinical-Chemistry-Analyzer--Beckman-Coulter-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
    EU-012012-001
  • Acción
    Modification of instructions. Updating the previously published information.
Notificaciones De Seguridad De Campo acerca de Aurinio L 50
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2015-92944
  • 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--Aurinio-L-50--Trilux-Medical-GmbH--Co-KG/#
  • 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
    200174254
  • Acción
    Information on the risk of use. Modification of products.
Notificaciones De Seguridad De Campo acerca de Aurinio OP-fittings
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2018-6307
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2018/Medicinsk-elektriskmekanisk-utrustning--Aurinio-OP-armaturer--Trilux-Medical-GmbH--Co-KG/#
  • 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
    200205485
  • Acción
    Information on the risk of use. Modification of products. Temporary measures.
Notificaciones De Seguridad De Campo acerca de AUTO CHECK 5+ Level 2
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2017-66024
  • 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/In-vitro-diagnostiska-produkter--AUTOCHECK-5-Niva-2--Radiometer-Medical-ApS/#
  • 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
    FAN 915-370
  • Acción
    Products should be taken out of service.
Notificaciones De Seguridad De Campo acerca de AutoDELFIA thyroid analyzer
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2014-70551
  • 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/In-vitro-diagnostiska-produkter--AutoDELFIA-tyreoideaanalyser--Wallac-Oy/#
  • 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
    R2014003
  • Acción
    Temporary measures. Modification of the software.
Notificaciones De Seguridad De Campo acerca de AUTOGEN DR ICD and AUTOGEN CRT-D
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2014-95685
  • 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/Aktiva-implantat--AUTOGEN-DR-ICD-och-AUTOGEN-CRT-D--Boston-Scientific-CRM/#
  • 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
    100000023523-FA
  • Acción
    Information on the risk of use. Modification of the software. Temporary measures.
Notificaciones De Seguridad De Campo acerca de Automated Hematology Analyzer pand-100i and Automa...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2013-28410
  • 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/In-vitro-diagnostiska-produkter--Automated-Hematology-Analyzer-pocH-100i-och-Automated-Hematology-Analyzer-XP-300--Sysmex-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
    FSCA-1215
  • Acción
    Information on the risk of use. Modification of the software. Modification of products.
Notificaciones De Seguridad De Campo acerca de Automated Hematology Analyzer XN-10 and XN-20
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2013-90394
  • 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/In-vitro-diagnostiska-produkter--Automated-Haematology-Analyser-XN-10-och-XN-20--Sysmex-Japan-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
    SEG Minerva 594900011
  • Acción
    Information on the risk of use. Temporary measures.
Notificaciones De Seguridad De Campo acerca de AutoSet CS, AutoSet CS PacaWave, AutoSet CS2, Auto...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2015-40544
  • 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/Anestesi--och-andningsstodjande-produkter--AutoSet-VPAP-Tx-S9-Autoset-och-AirCurve--ResMed-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
    CA0311
  • Acción
    Warning information. Follow-up patient.
Notificaciones De Seguridad De Campo acerca de Autostainer Link 48 and DakoLink
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2014-71122
  • 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/In-vitro-diagnostiska-produkter--Autostainer-Link-48-och-DakoLink--Dako-North-America-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
    CAPA00441
  • Acción
    Modification of products. Modification of the software.
Notificaciones De Seguridad De Campo acerca de Avaira Sphere marketed under the name Eye Q All Da...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2011/86895
  • 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/Kontaktlinser--Avaira-Sphere-Eye-Q-All-Day-Enfilcon-DK-100-Aspeheric-My-Vision-Monthly-Options-Evolve--CooperVision-Manufacturing/#
  • 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
    3005724763-08192011-001-R
  • Acción
    Withdrawal of the products. Rest Topic (silicone) on the lenses can cause blurred vision, discomfort, severe eye pain or eye injuries.
Notificaciones De Seguridad De Campo acerca de Avance, Amingo, Avance CS2 and AISYS
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2013-96366
  • 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/Anestesi--och-andningsstodjande-produkter--Avance-Amingo-Avance-CS2-och-Aisys--Datex-Ohmeda-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 34058
  • Acción
    Information on the risk of use. Modification of the software.
Notificaciones De Seguridad De Campo acerca de Avant & Primo2x Families Adult and Lilliput Pediat...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2016-50158
  • 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/Medicinsk-elektriskmekanisk-utrustning--Avant--Primo2x-Families-Adult-och-Lilliput-Pediatric-Oxygenator-Mounting-Brackets--Sorin-Group-Italia-srl/#
  • 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
    FSCA02-16
  • Acción
    Products should be revoked.
Notificaciones De Seguridad De Campo acerca de Avant Guard 800 and Avant Guard 801 beds
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2014-18968
  • 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/Hjalpmedel-for-funktionshindrade--AvantGuard-800-och-AvantGuard-801-sangar--Hill-Rom-SAS/#
  • 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
    Information on the risk of use. Modification of products.
Notificaciones De Seguridad De Campo acerca de Avant, Avant LW and Salsa
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2012/15218
  • 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/Rollatorer--Avant-Avant-LW-och-Salsa--Etac-Supply-Center-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
    Etac395
  • Acción
    Control of products. Modification of products.
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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.

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