Events

Rappel de C-Series LiftsPrism Medical/Waverly Glen FSN-0016A

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Rehab Assist Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-01442-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-12-11
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01442-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Rehab assist has been made aware by prism medical usa (a division of handicare), that during an internal cycle testing of c-series lifts it is determined that the c-series lift straps for lifts manufactured between april 25, 2017 and june 12, 2017 may wear prematurely at max load (625lbs). the root cause has been identified as a supplied component that was not to specification. if the strap wears during use there is a potential risk for the person being supported by the lift to drop.There have been no known incidents of hoists in use, only in internal routine cyclical testing.
  • Action
    Rehab Assist will be in contact with affected customers to arrange for replacement of affected devices. This recall action only relates to the serial numbers stated for this Sponsor.

Device

C-Series LiftsPrism Medical/Waverly Glen FSN-0016A
  • Modèle / numéro de série
    C-Series LiftsPrism Medical/Waverly Glen FSN-0016AItem Numbers: 1-323100, 1-323211, 1-323149Model 323100 C450 Manual Traverse Serial Numbers C4M0018959 and C4M0018962Model 323211 C450 Manual Traverse Rev A Serial Number C4M0018956Model 323149 C450 Power Traverse Serial Number C4P0009806ARTG Number: 169639
  • Manufacturer
    Rehab Assist Pty Ltd

Manufacturer

Rehab Assist Pty Ltd