Events

Recall of Prism Medical P300 and C300 Lifts

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Rehab Assist Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00967-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-09-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00967-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    Prism has been made aware of 17 incidents involving 300 series lifts in which the drive gear shaft has broken, eliminating the lifts ability to raise or lower a patient. of these 17 incidents we have discovered 3 in which the free fall protection system did not engage properly. if both of these incidents occur atthe same time there is a risk for the person being supported by the lift to drop unexpectedly. the patients involved in the 3 incidents were not seriously injured and did not require medical attention.
  • Action
    Rehab Assist will replacing the affected units with a new unit. For further information please see https://www.tga.gov.au/alert/prism-medical-p300-and-c300-ceiling-hoist. This action has been closed-out on 18/08/2016.

Device

Prism Medical P300 and C300 Lifts
  • Model / Serial
    Prism Medical P300 and C300 LiftsLifter P300Models: 303050; 303051Serial: P303470 – 479, P304158/164/171/172, P304536 – 539, P304866/867, P305116/118, P305125 – 127, P305130/134/135Lifter C300Models: 330050; 330053Serial: C303221/224/225, CQ303107 – 116Lifts manufactured prior to 8 June 2015ARTG Number: 169639
  • Manufacturer
    Rehab Assist Pty Ltd

Manufacturer

Rehab Assist Pty Ltd