Events

Avis De Sécurité sur Action® 2000 Manual 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(28)
  • Date
    2011-11-24
  • 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=/action-2000-manual-wheelchairs&id=6581f825-9782-6eee-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
    In august 2007, invacare changed the method of mounting the castor assembly to the sideframe. the thread length on the bolts used to mount the castors were found to be insufficient to guarantee that the bolts can be correctly tightened. loose bolts could potentially cause the sudden failure of one or both of the castor housing bolts, and the possibility of a fall from the wheelchair which could result in injury to the user.
  • Action
    The IMB advises that users:  1. Ensure the appropriate personnel are made aware of this notice.  2. Identify the location of all affected wheelchairs.  3. If you / your institution have affected 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

Action® 2000 Manual Wheelchairs
  • Modèle / numéro de série
  • Description du dispositif
    Action® 2000 Manual Wheelchairs
  • Manufacturer
    Invacare Ireland Limited

Manufacturer

Invacare Ireland Limited