Events

Recall of Carina Mobile LiftsAll Models and Series

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Active Medical Supplies 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-2017-RN-00516-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00516-1
  • 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
    The manufacturer, handicare, has identified the possibility that the carina mobile lift could be mounted incorrectly by users in two respects. namely, the lift arm and actuator could be incorrectly mounted and/or the mast with lift arm could be incorrectly mounted.If the connection between lift arm and actuator is incorrectly mounted, there is a possibility that a metal part on top of the actuator (i.E. piston rod eye flange) fractures when subjected to certain weight loads. in the event that the mast is not fully inserted into the mast base and standing upright in a vertical position, there is a possibility that the mast falls forward when subjected to weight load. therefore, there is a risk that an incorrectly mounted mobile lift would cause injury upon use.
  • Action
    Active Medical Supplies is requesting users to follow the additional instructions regarding the inspection of the connection between the lift arm and actuator as well as the positioning of the mast to prevent incorrect mounting of the mobile lifts. The instructions are contained in Annexes A and B (respectively) of the recall notification and are intended to supplement the Instructions for Use (IFU). Users are advised that the updated IFU is available for download from the manufacturer's website.

Device

Carina Mobile LiftsAll Models and Series

Manufacturer

Active Medical Supplies Pty Ltd