Events

Avis De Sécurité sur Storm3 Range (including Storm3 TT), Typhoon I & Typhoon II Power Wheelchairs

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

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
    SN2011(25)
  • Date
    2011-11-11
  • 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=/storm3-range-(including-storm3-tt)-typhoon-i-typhoon-ii-power-wheelchairs&id=f281f825-9782-6eee-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
    Invacare issued a field safety notice informing their customers of an update to transportation information provided in the user manual for the storm3 and typhoon range power wheelchairs. users of storm3 and typhoon range power wheelchairs should read the attached invacare field safety notice to determine if this information may have an impact on their transportation requirements.
  • Action
    The IMB advises that users:  1. Ensure the appropriate personnel are made aware of this notice.  2. Identify the location of all affected power wheelchairs.  3. If you / your institution have affected power wheelchairs, follow the manufacturer’s recommendations as outlined in the attached field safety notice and ensure that the corrective action is completed on all affected medical devices.

Device

Storm3 Range (including Storm3 TT), Typhoon I & Typhoon II Power Wheelchairs
  • Modèle / numéro de série
  • Description du dispositif
    Storm3 Range (including Storm3 TT), Typhoon I & Typhoon II Power Wheelchairs
  • Manufacturer
    Invacare Ireland Limited

Manufacturer

Invacare Ireland Limited