Events

Recall of 500 Series Vertical Rails

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by SP Homecare 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-00602-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-06-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00602-1
  • 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 bed rails do not comply with recent changes to iec 60601-2-38:1996 with regard to potential patient entrapment and side rail latches/ locks requirements.
  • Action
    Better Living care is requesting their customers and end users to quarantine all affected units. Better Living Care will arrange for the recovery and replacement of the devices.

Device

500 Series Vertical Rails
  • Model / Serial
    500 Series Vertical RailsPart Number: R21-PARTG Number:179151
  • Manufacturer
    SP Homecare Pty Ltd

Manufacturer

SP Homecare Pty Ltd
  • Source
    DHTGA