Events

Recall of Steris Amsco Warming Cabinet; War Cab Pre Glass Dual 24" 230V mobile; War Cab PTD Glass SGL 18” 230V

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies 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-2016-RN-00043-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-01-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00043-1
  • 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
    Steris has identified that some information printed on the quick reference magnet is incorrect; specifically, fahrenheit to celsius temperature conversions and the default warming cabinet temperature. it should be noted that all temperature information in the warming cabinet operator manual is correct. the risk to patients/users due to the reported issue is negligible.
  • Action
    The sponsor is advising users to discard the existing quick reference magnet and refer to the manual until the replacement quick reference magnet is received.

Device

Steris Amsco Warming Cabinet; War Cab Pre Glass Dual 24" 230V mobile; War Cab PTD Glass SGL 18” 230V
  • Model / Serial
    Steris Amsco Warming CabinetWar Cab Pre Glass Dual 24" 230V mobileProduct Code: ST-DJ06014433112Serial Numbers: 0408215020 and 0408215021War Cab PTD Glass SGL 18” 230VProduct Code: ST-DJ050144132Serial Numbers: 0423315089ARTG Number: 167720
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd