Events

Recall of AvantGuard 1600 Li160A0(Hospital bed)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Hill-Rom 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-2016-RN-00253-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-03-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00253-1
  • 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
    Hill-rom has received reports that the backrest actuator on the avantguard 1600 beds may experience a jolted motion, noise (clanking or chattering), premature wear, or backrest functionality loss when a load is applied to the backrest section. these issues do not affect the cpr functionality in case of emergency.The reported issue is unlikely to cause adverse health consequences.
  • Action
    Hill-Rom has developed a correction and will contact the affected facilities to modify the affected beds. The CPR function is still operational in case of emergency. For this reason, the device can continue to be used whilst awaiting the correction. If however, the unit experiences a loss of backrest functionality, users are advised to take it out of service and contact Hill-Rom.

Device

AvantGuard 1600 Li160A0(Hospital bed)
  • Model / Serial
    AvantGuard 1600 Li160A0(Hospital bed)Models: CS160A0005XXX & PRS160A0005XXXSerial Numbers: HRP001288830 to HRP002497322Manufactured between June 2009 and December 2015.ARTG number: 127268
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd