Events

Recall of Aegis Standing Sling - Lift, patient transfer, sling/harness/strap

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Solari Medical.

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-00308-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-04-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00308-1
  • 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
    During the use of the device it was noticed by the healthcare professional that the stitching on one of the loops holding the sling to the spreader bar of the hoist had come loose. no harm came to the patient or the healthcare worker. the stitching had become loose after more than twelve months use due to either wear or inadequate back stitching and could have been exacerbated if the operator had incorrectly twisted the loop when attaching it to the spreader bar.
  • Action
    Solaris Medical is contact end users through the distributors to advise of the potential issue. Solaris Medical will inspect all potentially affected units and repair if damaged. This action has been closed-out on 15/08/2016.

Device

Aegis Standing Sling - Lift, patient transfer, sling/harness/strap
  • Model / Serial
    Aegis Standing Sling - Lift, patient transfer, sling/harness/strapARTG Number: 203097
  • Manufacturer
    Solari Medical

Manufacturer

Solari Medical
  • Source
    DHTGA