Events

Avis De Sécurité sur AccessAED PAD, AccessAED and AccessALS Automated External Defibrillator Devices

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Access CardioSystems Inc..

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Numéro de l'événement
    SN2004(10)
  • Date
    2004-11-15
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/accessaed-pad-accessaed-and-accessals-automated-external-defibrillator-devices&id=889af825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notes supplémentaires dans les données
  • Cause
    Recall of specified serial numbers of accessaed pad (model numbers 9100-0010-0 and 9100-0015-0), accessaed (model numbers 9100-0100-0, 9100-0100-1, 9100-0150-0, and 9100-0150-1), and accessals (model numbers 9100-0100-2 and 9100-0150-2) automated external defibrillator devices and discontinued support by the manufacturer of all other devices that are in use.
  • Action
    Ensure that relevant all staff are advised of this Safety Notice. Ensure that all specified serial numbers listed below are immediately removed from use: AccessAED PAD, AccessAED, AccessALS, serial numbers 075180 – 084760 Replace all other AEDs, not specified in the scope of the recall, as soon as possible

Device

AccessAED PAD, AccessAED and AccessALS Automated External Defibrillator Devices

Manufacturer

Access CardioSystems Inc.
  • Source
    HPRA