Events

Recall of V-PRO 1, V-PRO 1 Plus, V-PRO maX Low Temperature Sterilisation Systems Manufactured between 2 January 2014 and 2 May 2016

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-00803-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-06-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00803-1
  • 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 v-pro 1, v-pro 1 plus, and v-pro max sterilisers manufactured after 1 january 2014 may not display the correct date as of 29 february 2016. while the v-pro units display an incorrect date, the steriliser functions and cycle operations continue to operate properly. if users do not manually change the system date of the v-pro unit, the unit’s display and cycle printout will contain an incorrect date.
  • Action
    Device Technologies is advising users that a service technician will be upgrading all affected systems. Users are advised that the system date can be amended using the instructions found in the Operator's Manual. The system can continue to be used as normal until corrected. This action has been closed-out on 11/05/2017.

Device

V-PRO 1, V-PRO 1 Plus, V-PRO maX Low Temperature Sterilisation Systems Manufactured between 2 Jan...
  • Model / Serial
    V-PRO 1, V-PRO 1 Plus, V-PRO maX Low Temperature Sterilisation SystemsManufactured between 2 January 2014 and 2 May 2016ARTG Number: 154905
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd