Events

Recall of InTouch Critical Care Bed

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker 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-2014-RN-00727-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00727-1
  • 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
    Stryker has received complaints from the field regarding intouch beds, which allege that a caster has broken on the top of the caster stem where the brake rod inserts into the caster. these broken casters are identified when the intouch beds are hoisted or lifted from the floor during regular maintenance. if more than one caster on a unit is damaged, brake functions may be affected and result in reduced brake holding force. if only one caster on the bed is damaged, brake functionality continues to meet specifications.
  • Action
    A Stryker representative will perform an onsite inspection to determine if casters are affected. If affected the casters will be replaced. End users are reminded to not use the electronic brake to slow or stop the bed while it is in motion.

Device

InTouch Critical Care Bed
  • Model / Serial
    InTouch Critical Care Bed Item Number: 2156000000 All lots affectedARTG Number: 202755 (cancelled 21 March 2014)
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA