• À propos de cette base de données
  • Comment utiliser cette base de données
  • Téléchargez les données
  • FAQ
  • Crédits
Mode Liste Mode Grille
  • Dispositif médical 1003
  • Fabricant 257
  • Événement 124969
  • Implant 20
Avis De Sécurité sur headphone slim headphones with serial numbers from hps-1.0-2015-001 to hps-...
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    547
  • Date
    2017-11-03
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-nordicneurolab-dotycz%C4%85ca-wycofania-z-obrotu-i-u%C5%BCywania-s%C5%82uchawek
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    NordicNeuroLab AS security note regarding the recall and use of HeadPhone Slim (HPS) headsets with serial numbers from HPS-1.0-2015-001 to HPS-1.0-2016-051 and from 160052 to 160074
Avis De Sécurité sur power supplies for the lcd monitor with serial numbers lps-1.0-yyyy-xxx and...
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    5
  • Date
    2018-07-12
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-nordicneurolab-dotycz%C4%85ca-wycofania-z-obrotu-i-u%C5%BCywania-zasilaczy-do
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    NordicNeuroLab AS safety note regarding the withdrawal from the market and use of power supplies for the LCD monitor (power supply for LCD monitor) with serial numbers LPS-1.0-yyyy-xxx and LPS-1.1-yyyy-xxx
Avis De Sécurité sur neoplastin plus 10 and sta neoplastin plus
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    1108
  • Date
    2008-10-03
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/komunikat-firmy-diagnostica-stago-dotycz%C4%85cy-odczynnik%C3%B3w-neoplastin-plus-10-i-sta-neoplastin-plus
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    Diagnostica Stago's statement regarding reagents: Neoplastin Plus 10 and STA Neoplastin Plus (03/10/2008)
Avis De Sécurité sur anesthesia stations fabius, apollo and perseus with a mechanical mixer
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    462
  • Date
    2018-07-11
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-dr%C3%A4gerwerk-agco-kgaa-dotycz%C4%85ca-stanowisk-do-znieczulania-fabius-apollo
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    Drägerwerk AG & Co KGaA safety note for Fabius, Apollo and Perseus anesthesia stations with a mechanical mixer
Avis De Sécurité sur carbon dioxide collection points and oxygen intake points, in accordance wit...
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    870
  • Date
    2017-09-20
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-dr%C3%A4ger-medical-gmbh-dotycz%C4%85ca-punkt%C3%B3w-poboru-dwutlenku-w%C4%99gla-i-punkt%C3%B3w
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    Dräger Medical GmbH safety note regarding carbon dioxide collection points and oxygen intake points, in accordance with DIN 13260-2
Avis De Sécurité sur delta and gamma xxl patient monitors
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    1574
  • Date
    2011-07-29
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-dr%C3%A4ger-dotycz%C4%85ca-monitor%C3%B3w-pacjenta-delta-i-gamma-xxl
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    Dräger security note regarding Delta and Gamma XXL patient monitors
Rappel de XIO RADIATION TREATMENT PLANNING SYSTEM
  • Type d'événement
    Recall
  • ID de l'événement
    14987
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2009-10-15
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    If an auto port is created for a beam on focal the plan sent to xio & the beam edited it is possible the graphic beam representation & dose display do not agree with the edited field on the text page.
Avis De Sécurité sur dräger ac3000 monitor arm, parts with numbers g92756 and g04499
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    1307
  • Date
    2014-02-10
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-dr%C3%A4ger-medical-gmbh-dotycz%C4%85ca-ramienia-do-monitora-dr%C3%A4ger-ac3000-cz%C4%99%C5%9Bci
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    Safety note from Dräger Medical GmbH regarding the arm for the Dräger AC3000 monitor, parts with numbers G92756 and G04499
Avis De Sécurité sur dräger d-vapor / d-vapor 3000 evaporators with desfluran inhalation anesthetics
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    144
  • Date
    2016-04-21
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-dr%C3%A4ger-dotycz%C4%85ca-parownik%C3%B3w-dr%C3%A4ger-d-vapor-d-vapor-3000-z-anestetykiem
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    Dräger safety note for Dräger D-Vapor / D-Vapor 3000 evaporators with Baxter's Desfluran inhalation anesthetic in bottles
Avis De Sécurité sur dräger medical on anesthesia apparatus fabius tiro
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    1363
  • Date
    2008-07-04
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/komunikat-firmy-dr%C3%A4ger-medical-dotycz%C4%85cy-aparat%C3%B3w-do-znieczulania-fabius-tiro-04072008
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    Dräger Medical communication regarding anesthesia apparatus Fabius Tiro (04/07/2008)
Avis De Sécurité sur titus anesthesia machines
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    1456
  • Date
    2009-03-20
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/komunikat-firmy-dr%C3%A4ger-dotycz%C4%85cy-aparat%C3%B3w-do-znieczulania-typu-titus-20032009
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    Dräger communication on Titus anesthesia devices (20/03/2009)
Avis De Sécurité sur patient monitor arm holder
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    2446
  • Date
    2009-03-20
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/komunikat-firmy-dr%C3%A4ger-dotycz%C4%85cy-uchwytu-ramienia-monitora-pacjenta-20032009
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    Dräger communication regarding the patient monitor arm holder (20/03/2009)
Avis De Sécurité sur delta and gamma xxl patient monitors
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    2561
  • Date
    2010-06-24
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/komunikat-firmy-dr%C3%A4germedical-dotycz%C4%85cy-monitor%C3%B3w-pacjenta-delta-i-gamma-xxl-24062010
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    DrägerMedical communication regarding Delta and Gamma XXL patient monitors (24/06/2010)
Avis De Sécurité sur ecopharm tower air treatment systems
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    1878
  • Date
    2012-10-03
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-dr%C3%A4ger-dotycz%C4%85ca-system%C3%B3w-uzdatniania-powietrza-ecopharm-tower
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    Dräger safety note regarding EcoPharm Tower air treatment systems
Avis De Sécurité sur fabius gs premium anesthesia stations, tiro, tiro dm, mri, plus, plus xl
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    325
  • Date
    2018-03-12
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-dr%C3%A4gerwerk-dotycz%C4%85ca-stanowisk-do-znieczulania-fabius-gs-premium-tiro
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    Drägerwerk safety note regarding Fabius GS Premium anesthesia stations, Tiro, Tiro DM, MRI, plus, plus XL
Avis De Sécurité sur fabius mri anesthesia stations
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    1971
  • Date
    2015-07-02
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-dr%C3%A4ger-medical-dotycz%C4%85ca-stanowisk-do-znieczulania-fabius-mri
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    Dräger Medical safety note regarding Fabius MRI anesthesia stations
Avis De Sécurité sur incubators babytherm 8004 and 8010
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    361
  • Date
    2016-06-28
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-dr%C3%A4gerwerk-ag-co-kgaa-dotycz%C4%85ca-inkubator%C3%B3w-babytherm-8004-i-8010
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    Safety note from Drägerwerk AG & Co. KGaA regarding Babytherm 8004 and 8010 incubators
Avis De Sécurité sur incubators for newborns babytherm 8000wb, babytherm 8004 and babytherm 8010
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    2515
  • Date
    2014-09-01
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-dr%C3%A4ger-dotycz%C4%85ca-inkubator%C3%B3w-dla-noworodk%C3%B3w-babytherm-8000wb-babytherm
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    Dräger safety note regarding incubators for newborns Babytherm 8000WB, Babytherm 8004 and Babytherm 8010
Avis De Sécurité sur infinity acute care system , versions from vg2.2 to vg6.0 and standalone inf...
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    20
  • Date
    2018-02-22
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-dr%C3%A4ger-dotycz%C4%85ca-oprogramowania-infinity-acute-care-system-iacs-wersje
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    Dräger safety note regarding the Infinity Acute Care System (IACS), versions VG2.2 to VG6.0 and the standalone Infinity M540 patient monitor, versions VG2.2 to VG6.0
Avis De Sécurité sur infinity acute care system patient monitoring system and the infinity m540 ...
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    525
  • Date
    2018-03-26
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-draeger-medical-systems-dotycz%C4%85ca-systemu-monitorowania-pacjenta
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    Draeger Medical Systems safety note regarding the Infinity Acute Care System patient monitoring system (software versions from VG2.2 to VG4.1) and the Infinity M540 standalone patient monitor (software versions VG2.2 to VG4.1)
Rappel de TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)
  • Type d'événement
    Recall
  • ID de l'événement
    14709
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2017-06-05
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Bd has recently confirmed low level contamination of listeria monocytogenes on the listed lots of non-sterile prepared plated media containing sheep blood. bd has identified the source of the listeria contamination as sheep blood used in the manufacture of prepared media.
Avis De Sécurité sur jm-103 jaundice meter
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    1032
  • Date
    2018-06-08
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-dr%C3%A4ger-medical-systems-dotycz%C4%85ca-miernika-%C5%BC%C3%B3%C5%82taczki-jm-103
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    Dräger Medical Systems safety note regarding JM-103 jaundice meter
Avis De Sécurité sur jm-105 jaundice meter
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    643
  • Date
    2018-06-08
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-dr%C3%A4ger-medical-systems-dotycz%C4%85ca-miernika-%C5%BC%C3%B3%C5%82taczki-jm-105
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    Dräger Medical Systems safety note regarding the JM-105 jaundice meter
Avis De Sécurité sur no spo2 desaturation alarm in neonatal monitoring with the infinity acute ca...
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    1390
  • Date
    2013-11-27
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-dr%C3%A4ger-dotycz%C4%85ca-braku-alarmu-desaturacji-spo2-w-trybie-monitorowania
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    Dräger safety note regarding the absence of the SpO2 desaturation alarm in neonatal monitoring with the Infinity Acute Care System (IACS) with software version VG2.0.3 and higher
Avis De Sécurité sur unkown device
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    2558
  • Date
    2015-07-23
  • Pays de l'événement
    Poland
  • Source de l'événement
    ORMPMDBP
  • URL de la source de l'événement
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-dr%C3%A4ger-medical-dotycz%C4%85ca-opcjonalnego-%C5%BAr%C3%B3d%C5%82a-zasilania-ps500
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    Dräger Medical safety note regarding optional PS500 power supply used in conjunction with Evita Infinity V500, Babylog VN500 and Evita V300 respirators
  • 1
  • 2
  • 3
  • Truncate
  • Next
  • Last

À propos de cette base de données

Explorez plus de 120,000 rappels, alertes et avis de sécurité concernant les dispositifs médicaux, ainsi que leurs liens avec leurs fabricants.

  • FAQ
  • À propos de cette base de données
  • Contactez-nous
  • Crédits

Recevoir les newsletters de l'ICIJ

Vous travaillez dans le secteur médical? Vous avez vécu une expérience avec un dispositif médical? Notre projet n'est pas terminé. Nous souhaitons vous entendre.

Racontez-nous votre histoire !

Avertissement

Les dispositifs médicaux contribuent à diagnostiquer, prévenir et traiter de nombreuses blessures et maladies. Nous ne suggérons ou n'insinuons pas que des sociétés ou autres entités incluses dans la base de données internationale sur les dispositifs médicaux se livrent à un comportement illégal ou agissent de manière inappropriée. Le même implant peut avoir des noms différents selon les pays. Cette base de données n'a pas pour vocation de fournir des conseils aux patients. Ceux-ci doivent consulter leur médecin afin de déterminer si elle contient des informations pertinentes et si ces informations ont des implications médicales pour eux.

Téléchargez les données

La base de données internationale sur les dispositifs médicaux est sous licence Open Database License et ses contenus sous licence Creative Commons Attribution-ShareAlike. Toujours citer le Consortium international des journalistes d'investigation lorsque ces données sont utilisées. Vous pouvez télécharger une copie de la base de données ici.

Télécharger (zip)