Events

Recall of Akron Tilt Table couches

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Arjo Australia 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-2018-RN-00605-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00605-1
  • 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
    As part of post market surveillance (complaint reporting) monitoring, arjohuntleigh received a complaint related to akron tilt table middle section frame breakage. the investigation showed that one of the critical welds was missing. not all devices are affected by this defect, however, this issue is seen as a potential hazard and arjo australia seeks to prevent the possibility of any related event occurring again.There was no injury related to this incident.
  • Action
    ArjoHuntleigh is requesting customers: Complete and sign the Customer Response Form supplied with the customer letter and return this form to the local ArjoHuntleigh office as per the directions given. An ArjoHuntleigh Service person will contact the person you listed on the Customer Response Form to schedule service to verify and (if needed) rework your device, free of charge.

Device

Akron Tilt Table couches
  • Model / Serial
    Akron Tilt Table couchesSerial Numbers: P0167499 and P0418644Model Numbers: A8652 and A8652TProduct Codes: A8652 and A8652TARTG Number: 288419(Arjo Australia Pty Ltd - Table, examination/treatment)
  • Manufacturer
    Arjo Australia Pty Ltd

Manufacturer

Arjo Australia Pty Ltd
  • Source
    DHTGA