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  • Dispositivo 3
  • Fabricante 3
  • Evento 124969
  • Implante 0
Notificaciones De Seguridad De Campo acerca de glucose measurement with abl80 flex and abl80 flex...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1763
  • Fecha
    2012-07-06
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-radiometer-dotycz%C4%85ca-pomiaru-glukozy-gazometrami-abl80-flex-i-abl80
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Radiometer safety note regarding glucose measurement with gasometers ABL80 FLEX and ABL80 FLEX CO-OX
Notificaciones De Seguridad De Campo acerca de hematological analyzers unicel dxh 600 coulter and...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2675
  • Fecha
    2013-12-12
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-beckman-coulter-dotycz%C4%85ca-analizator%C3%B3w-hematologicznych-unicel-dxh-600
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Beckman Coulter safety note for the hematology analyzers UniCel DxH 600 Coulter and UniCel DxH 800 Coulter
Notificaciones De Seguridad De Campo acerca de hematological analyzers unicel dxh 800 and unicel ...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2460
  • Fecha
    2014-08-01
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-beckman-coulter-dotycz%C4%85ca-analizator%C3%B3w-hematologicznych-unicel-dxh-0
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Beckman Coulter safety note regarding the hematology analyzers UniCel DxH 800 and UniCel DxH 600
Notificaciones De Seguridad De Campo acerca de hematological analyzers unicel dxh 800 and unicel ...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    375
  • Fecha
    2017-05-18
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-beckman-coulter-dotycz%C4%85ca-analizator%C3%B3w-hematologicznych-unicel-dxh-2
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Beckman Coulter safety note regarding the hematology analyzers UniCel DxH 800 and UniCel DxH 600 Coulter
Notificaciones De Seguridad De Campo acerca de hematological analyzers unicel dxh 800 coulter and...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1002
  • Fecha
    2017-01-26
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-beckman-coulter-dotycz%C4%85ca-analizator%C3%B3w-hematologicznych-unicel-dxh-1
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Beckman Coulter safety note regarding the hematology analyzers UniCel DxH 800 Coulter and UniCel DxH 600 Coulter
Notificaciones De Seguridad De Campo acerca de hematological analyzers unicel dxh 800 coulter and...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1585
  • Fecha
    2014-03-10
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/zaktualizowana-notatka-bezpiecze%C5%84stwa-firmy-beckman-coulter-dotycz%C4%85ca-analizator%C3%B3w-hematologicznych
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Updated Beckman Coulter safety note for the UniCel DxH 800 Coulter and UniCel DxH 600 Coulter hematology analyzers
Notificaciones De Seguridad De Campo acerca de mosaiq radiotherapy system
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1551
  • Fecha
    2014-05-29
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-impac-medical-systems-dotycz%C4%85ca-systemu-do-radioterapii-mosaiq
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    IMPAC Medical Systems safety note regarding the MOSAIQ radiotherapy system
Notificaciones De Seguridad De Campo acerca de hematology analyzers lh 750 and lh 780
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2322
  • Fecha
    2013-12-12
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-beckman-coulter-dotycz%C4%85ca-analizator%C3%B3w-hematologicznych-lh-750-i-lh-780
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Beckman Coulter safety note for hematology analyzers LH 750 and LH 780
Notificaciones De Seguridad De Campo acerca de hematology analyzers lh 750 and lh 780 and reagent...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1868
  • Fecha
    2014-03-12
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-aktualizacja-fsn-22198-firmy-beckman-coulter-dotycz%C4%85ca-analizator%C3%B3w
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Safety note (update FSN 22198) by Beckman Coulter for hematology analyzers LH 750 and LH 780 and reagents Coulter LH Cleaner and Coulter Clenz
Notificaciones De Seguridad De Campo acerca de hematology analyzers unicel dxh 800 coulter, pn 62...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2319
  • Fecha
    2013-10-10
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-beckman-coulter-dotycz%C4%85ca-analizator%C3%B3w-hematologicznych-unicel-dxh-800
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Beckman Coulter safety note regarding the hematology analyzers UniCel DxH 800 Coulter, PN 629029 and UniCel DxH 600 Coulter, PN B23858
Notificaciones De Seguridad De Campo acerca de hemocue glucose 201 microcuvette.
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2222
  • Fecha
    2011-06-02
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-hemocue-dotycz%C4%85ca-mikrokuwet-hemocue-glucose-201
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    HemoCue safety note for the HemoCue Glucose 201 microcuvette.
Notificaciones De Seguridad De Campo acerca de incorrect marking of alarm connections in asp6025 ...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    38
  • Fecha
    2017-07-19
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-leica-biosystems-nussloch-gmbh-dotycz%C4%85ca-nieprawid%C5%82owego-oznaczenia
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Leica Biosystems Nussloch GmbH safety note regarding the incorrect marking of alarm connections in ASP6025 tissue processing equipment with some serial numbers
Notificaciones De Seguridad De Campo acerca de inonet computers - mayflower pc used with analyzer...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2406
  • Fecha
    2014-07-18
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-beckman-coulter-dotycz%C4%85ca-komputer%C3%B3w-inonet-%E2%80%93-mayflower-pc-stosowanych
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Beckman Coulter safety note regarding InoNet - Mayflower PC computers used with AU480, AU680 and PK7300 analyzers
Notificaciones De Seguridad De Campo acerca de mosaiq software
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1081
  • Fecha
    2017-07-12
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-fca-ims-0024-firmy-impac-medical-systems-dotycz%C4%85ca-oprogramowania-mosaiq
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Safety note (FCA-IMS-0024) from IMPAC Medical Systems for MOSAIQ software
Notificaciones De Seguridad De Campo acerca de interference in enzyme creatinine , hdl cholestero...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    131
  • Fecha
    2018-09-24
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-fsn-000053-firmy-beckman-coulter-dotycz%C4%85ca-interferencji-w-oznaczeniach-0
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Safety note (FSN-000053-A) by Beckman Coulter on interference in enzyme Creatinine (OSR6x204), HDL cholesterol (OSR6x87), lipase (OSR6x30) and uric acid (OSR6x98)
Notificaciones De Seguridad De Campo acerca de interference in enzyme creatinine , hdl cholestero...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    427
  • Fecha
    2018-09-10
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-fsn-000053-firmy-beckman-coulter-dotycz%C4%85ca-interferencji-w-oznaczeniach
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Safety note (FSN-000053-A) by Beckman Coulter on interference in enzyme Creatinine (OSR6x204), HDL cholesterol (OSR6x87), lipase (OSR6x30) and uric acid (OSR6x98)
Notificaciones De Seguridad De Campo acerca de iq200 series system for microscopic urinalysis wit...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    384
  • Fecha
    2017-11-29
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-beckman-coulter-dotycz%C4%85ca-systemu-iq200-series-do-mikroskopowej-analizy
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Beckman Coulter safety note regarding iQ200 Series system for microscopic urine analysis with barcode scanner, model NFT-2100
Notificaciones De Seguridad De Campo acerca de leica m525 f20 microscopic systems
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    679
  • Fecha
    2018-09-13
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-capa-her-md-18-001-firmy-leica-microsystems-dotycz%C4%85ca-system%C3%B3w-mikroskopowych
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Leica Microsystems safety note (CAPA-HER-MD-18-001) for Leica M525 F20 microscopic systems
Notificaciones De Seguridad De Campo acerca de microscan labpro information management system in ...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2551
  • Fecha
    2015-08-19
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-beckman-coulter-dotycz%C4%85ca-systemu-zarz%C4%85dzania-informacjami-microscan
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Beckman Coulter security note regarding the MicroScan LabPro information management system from version 1.0 to 4.11
Notificaciones De Seguridad De Campo acerca de microscan labpro information management system ver...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1345
  • Fecha
    2015-08-24
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-beckman-coulter-dotycz%C4%85ca-systemu-zarz%C4%85dzania-informacjami-microscan-0
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Beckman Coulter security note regarding the MicroScan LabPro information management system from version 1.0 to 4.11 - patch
Notificaciones De Seguridad De Campo acerca de microscan labpro information management system ver...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1527
  • Fecha
    2016-03-21
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-beckman-coulter-dotycz%C4%85ca-systemu-zarz%C4%85dzania-informacjami-microscan-1
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Beckman Coulter security note regarding the MicroScan LabPro information management system from version 1.0 to 4.41 - update
Notificaciones De Seguridad De Campo acerca de microscopic urine analyzer series iq200
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1047
  • Fecha
    2018-03-21
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-beckman-coulter-dotycz%C4%85ca-mikroskopowego-analizatora-moczu-serii-iq200
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Beckman Coulter safety note for the iQ200 microscopic urine analyzer
Notificaciones De Seguridad De Campo acerca de microstrep plus 1 panels , microstrep plus 2 and ...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1522
  • Fecha
    2015-09-24
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/2015-09-24-andkar-drukuj-1-2-3-za%C5%82%C4%85czniki-do-pobrania-pdf-fsnbeckmancoulter24092015pdf-2372-kb
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Beckman Coulter safety note regarding the MICROSTREP plus 1 panels (cat. No. B1027-201), MICroSTREP plus 2 (cat. No. B1027-202) and MICroSTREP plus 3 (cat. No. B1016-89A)
Notificaciones De Seguridad De Campo acerca de novel direct and novel perfect onepiece
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2741
  • Fecha
    2008-02-08
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/komunikat-dot-bezpiecze%C5%84stwa-implant%C3%B3w-stom-nobeldirect-i-nobelperfect-onepiece-otrzymany-wraz-z
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Message regarding the safety of stoma implants "NobelDirect" and "NobelPerfect Onepiece" received together with the report from Novel Biocare (08.02.2008)
Notificaciones De Seguridad De Campo acerca de immunochemical analyzers from the access 2 family,...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    392
  • Fecha
    2017-03-23
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-beckman-coulter-dotycz%C4%85ca-analizator%C3%B3w-immunochemicznych-z-rodziny
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Beckman Coulter safety note regarding the immunochemical analyzers from the Access 2 family, i.e. Access 2 analyzers, Access 2 Remanufactured and the Access UniCel DxC 600i integrated platform SYNCHRON
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