Events

Recall of Steris - VPro sterilizer

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Steris Corporation.

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
    20305
  • Event Initiated Date
    2016-06-22
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Reason
    V-pro® 1, v-pro® 1 plus, and v-pro® max sterilizers manufactured after january 1, 2014 may not display the correct date as of february 29, 2016. although the units display an incorrect date, the sterilizer functions and cycle operations continue to operate properly therefore safety and effectiveness is not impacted by the incorrect system date.
  • Action
    Software to be upgraded

Device

Steris - VPro sterilizer
  • Model / Serial
    Model: V-PRO 1, V-PRO 1 Plus, V-PRO maX low, Affected: V-PRO family
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Manufacturer Parent Company (2017)
    Steris Plc
  • Source
    NZMMDSA