Events

Avis De Sécurité sur Oxy-Top 5 / Oxy-Tec 5 Oxygen Concentrator

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par YSM Medical & Rehabilitation Equipment Ltd.

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
    SN2009(12)
  • Date
    2009-12-10
  • 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=/oxy-top-5-oxy-tec-5-oxygen-concentrator&id=548cf825-9782-6eee-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
    Risk of ignition of oxy-top 5 / oxy-tec 5 oxygen concentrators.
  • Action
    Advice for Retailers and Wholesalers  (1) Retailers and wholesalers should examine their stock to determine if they have any medical devices branded Oxy-Top 5 / Oxy-Tec 5 oxygen concentrators.  (2) If you have these devices, cease sale of these devices immediately and quarantine all stock. Contact the IMB immediately to obtain further instruction and guidance.  (3) Ensure the appropriate personnel are made aware of this notice.  Advice for Healthcare Institutions / Consumers  (1) Check your oxygen concentrator to determine if it is branded Oxy-Top 5 / Oxy- Tec 5.  (2) Examine the information for use provided with the device to determine if either the name or manufacturer details match those provided above.  (3) If you find that you have one of these devices, discontinue use immediately and seek an alternative. Please quarantine the device and contact the IMB to obtain further instruction and guidance.  (4) Ensure the appropriate personnel are made aware of this notice.

Device

Oxy-Top 5 / Oxy-Tec 5 Oxygen Concentrator

Manufacturer

YSM Medical & Rehabilitation Equipment Ltd
  • Source
    HPRA