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  • Dispositivo 5
  • Fabricante 3
  • Evento 124969
  • Implante 0
Notificaciones De Seguridad De Campo acerca de high-energy c-series linear accelerators
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2507
  • Fecha
    2014-07-15
  • 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-varian-medical-systems-dotycz%C4%85ca-wysokoenergetycznych-akcelerator%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
    Varian Medical Systems safety note for high-energy C-Series linear accelerators (Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac CX, Clinac 2100 C / D, Clinac 2300C / D, Clinac DX, Clinac 21 EX, Clinac 23 EX)
Notificaciones De Seguridad De Campo acerca de high-energy devices clinacs and truebeam
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2430
  • Fecha
    2011-06-09
  • 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-varian-dotycz%C4%85ca-wysokoenergetycznych-urz%C4%85dze%C5%84-clinacs-i-truebeam
  • 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
    Varian's safety note on high-energy Clinacs and TrueBeam devices
Notificaciones De Seguridad De Campo acerca de obi 1.3, obi 1.4, obi 1.5 and truebeam 1.0 and off...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1567
  • Fecha
    2011-11-21
  • 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-varian-dotycz%C4%85ca-system%C3%B3w-obi-13-obi-14-obi-15-i-truebeam-10-oraz
  • 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
    Varian's safety note regarding OBI 1.3, OBI 1.4, OBI 1.5 and TrueBeam 1.0 and Offline Review 1.0 - 2.0
Notificaciones De Seguridad De Campo acerca de collimator accessories for the c-series clinac, tr...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2468
  • Fecha
    2011-08-04
  • 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-varian-dotycz%C4%85ca-akcesori%C3%B3w-kolimatora-sto%C5%BCkowego-do-platform-c-series
  • 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
    Varian safety note regarding the accessories of a conical collimator for the C-Series Clinac, Trilogy, Trilogy Tx and Novalis Tx platforms.
Notificaciones De Seguridad De Campo acerca de unkown device
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1277
  • Fecha
    2011-05-06
  • 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-varian-dotycz%C4%85ca-platformy-prowadzenia-optycznego-optical-guidance
  • 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
    Varian safety note regarding the Optical Guidance Platform, version 2.6 and 2.6.1
Notificaciones De Seguridad De Campo acerca de portal vision system and r-arm arm with the 4d int...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2595
  • Fecha
    2012-02-29
  • 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-varian-dotycz%C4%85ca-systemu-portal-vision-i-ramienia-r-arm-z-aplikacj%C4%85-4d
  • 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
    Varian safety note regarding the Portal Vision system and the R-Arm arm with the 4D Integrated Treatment Console application.
Notificaciones De Seguridad De Campo acerca de acl top analyzers
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2628
  • Fecha
    2014-07-16
  • 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-instrumentation-laboratory-dotycz%C4%85c%C4%85-analizator%C3%B3w-acl-top
  • 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
    Instrumentation Laboratory safety note regarding ACL TOP analyzers
Notificaciones De Seguridad De Campo acerca de ring probes used in brachytherapy ring applicators
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2014
  • Fecha
    2014-04-17
  • 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-varian-medical-systems-dotycz%C4%85ca-sond-pier%C5%9Bcieniowych-stosowanych-w
  • 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
    Varian Medical Systems safety note regarding ring probes used in brachytherapy ring applicators
Notificaciones De Seguridad De Campo acerca de rpm respiratory gating system software version 1.7...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1864
  • Fecha
    2013-05-10
  • 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-varian-dotycz%C4%85ca-oprogramowania-rpm-respiratory-gating-system-w-wersji
  • 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
    Varian safety note regarding the RPM Respiratory Gating System version 1.7.5 software with 3D option
Notificaciones De Seguridad De Campo acerca de exact arm joint motor shaft in on-board imager dev...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1711
  • Fecha
    2014-04-23
  • 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-varian-medical-system-dotycz%C4%85ca-wa%C5%82u-silnika-przegubu-ramienia-exact-w
  • 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
    Varian Medical System Safety Note on the Exact Arm Joint Motor shaft in On-Board Imager
Notificaciones De Seguridad De Campo acerca de clinac linear accelerator
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1103
  • Fecha
    2011-03-23
  • 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-varian-dotycz%C4%85ca-akceleratora-liniowego-varian-clinac
  • 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
    Varian's safety note on the Varian Clinac Linear Accelerator.
Notificaciones De Seguridad De Campo acerca de clinac linear accelerator
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2518
  • Fecha
    2011-03-23
  • 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-varian-dotycz%C4%85ca-akceleratora-liniowego-varian-clinac-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
    Varian's safety note on the Varian Clinac Linear Accelerator.
Notificaciones De Seguridad De Campo acerca de truebeam treatment system, truebeam stx, vitalbeam...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    447
  • 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-cp-2018-01713-firmy-varian-medical-systems-dotycz%C4%85ca-systemu-prowadzenia
  • 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 (CP-2018-01713) by Varian Medical Systems regarding the TrueBeam treatment system, TrueBeam STx, VitalBeam and EDGE
Notificaciones De Seguridad De Campo acerca de type iii wedge assemblies in all varian clinacs sy...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1281
  • Fecha
    2011-04-20
  • 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-varian-dotycz%C4%85ca-zespo%C5%82%C3%B3w-klina-typu-iii-we-wszystkich-systemach-varian
  • 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
    Varian's safety note regarding type III wedge assemblies on all Varian Clinacs systems.
Notificaciones De Seguridad De Campo acerca de varian clinac® accelerators with mlc mark or mille...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2623
  • Fecha
    2012-02-20
  • 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-varian-dotycz%C4%85ca-przyspieszaczy-varian-clinac%C2%AE-z-kolimatorami-mlc-mark
  • 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
    VARIAN safety note regarding Varian Clinac® accelerators with MLC Mark or Millennium collimators and MLC BrainLAB m3 collimator
Notificaciones De Seguridad De Campo acerca de brachyvision device
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1771
  • Fecha
    2010-08-17
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/komunikat-firmy-varian-dotycz%C4%85cy-urz%C4%85dzenia-brachyvision-17082010
  • 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
    Varian's announcement regarding the BrachyVision device (17/08/2010)
Notificaciones De Seguridad De Campo acerca de quava balconies with some serial numbers
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    967
  • Fecha
    2018-06-15
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-fsca-2018k093-firmy-vermeiren-group-dotycz%C4%85ca-wycofania-z-obrotu-i-u%C5%BCywania
  • 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 (FSCA-2018K093) of the Vermeiren Group company regarding the withdrawal and use of Quava balconies with certain serial numbers
Notificaciones De Seguridad De Campo acerca de switch cannula series
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    420
  • Fecha
    2017-01-27
  • 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-vigmed-ab-dotycz%C4%85ca-wycofania-z-obrotu-i-z-u%C5%BCywania-niekt%C3%B3rych-serii
  • 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
    Vigmed AB safety notice regarding the withdrawal and use of some SWiTCH cannula series
Notificaciones De Seguridad De Campo acerca de vital healthcare sdn. bhd. concerning the withdraw...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    702
  • Fecha
    2018-05-15
  • 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-vital-healthcare-sdn-bhd-dotyczaca-wycofania-z-obrotu-i-u%C5%BCywania
  • 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
    Vital Healthcare Security Note Sdn. Bhd. concerning the withdrawal from use and use of certain sets of NovaLine hemodialysis tubing
Notificaciones De Seguridad De Campo acerca de hospital beds völker 2080, 2082, s 280 and s 282
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1066
  • Fecha
    2016-04-26
  • 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-v%C3%B6lker-gmbh-dotycz%C4%85ca-%C5%82%C3%B3%C5%BCek-szpitalnych-v%C3%B6lker-2080-2082-s-280-i-s-282
  • 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
    Völker GmbH safety note regarding hospital beds Völker 2080, 2082, S 280 and S 282
Notificaciones De Seguridad De Campo acerca de hospital beds völker 2080, 2082, s 280 and s 282, ...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    475
  • Fecha
    2016-06-17
  • 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-v%C3%B6lker-gmbh-dotycz%C4%85ca-%C5%82%C3%B3%C5%BCek-szpitalnych-v%C3%B6lker-2080-2082-s-280-i-s-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
    Völker GmbH safety note for hospital beds Völker 2080, 2082, S 280 and S 282, with side trigger button for side handrails
Notificaciones De Seguridad De Campo acerca de gore tag thoracic endoprosthesis
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    576
  • Fecha
    2017-10-24
  • 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-w-l-gore-associates-inc-dotycz%C4%85ca-endoprotezy-aorty-piersiowej-gore-tag
  • 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 from WL Gore & Associates Inc. regarding the GORE TAG thoracic endoprosthesis
Notificaciones De Seguridad De Campo acerca de automatic intraosseous nio-a for adults
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    949
  • Fecha
    2016-10-12
  • 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-waismed-ltd-dotycz%C4%85ca-wycofania-z-obrotu-i-u%C5%BCywania-niekt%C3%B3rych-partii
  • 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
    WaisMed Ltd. safety note regarding the withdrawal from the market and use of some batches of an automatic intraosseous entry for adults NIO-A
Notificaciones De Seguridad De Campo acerca de ultrasonographs with the software version from 12....
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    347
  • Fecha
    2018-03-12
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-esaote-dotycz%C4%85ca-ultrasonograf%C3%B3w-z-wersj%C4%85-oprogramowania-od-1210-do
  • 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
    Esaote safety note regarding ultrasonographs with software version from 12.10 to 13.60 and elastography option enabled (ElaXto)
Notificaciones De Seguridad De Campo acerca de battery in the medumat transport respirator
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    369
  • Fecha
    2018-07-03
  • 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-weinmann-emergency-medical-technology-gmbh-co-kg-dotycz%C4%85ca-prawid%C5%82owego
  • 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 from WEINMANN Emergency Medical Technology GmbH + Co. KG on the correct attachment of the battery in the MEDUMAT Transport respirator
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