Events

Recall of WATO EX-65 and A-Series (A5/A7) anaesthesia machines

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Mindray Medical 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-2017-RN-01066-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01066-1
  • 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
    Mindray has identified a potential issue related to electrically erasable programmable read-only memory (eeprom) which will only occur if the system’s total number of write cycles to a particular range of memory locations has exceeded the life specification of the eeprom. the issue will only manifest at start up or at the end of a case; it will not occur during a case. there are no adverse effects on the patient.To date, there have been no reports of injuries associated with this issue.
  • Action
    The manufacturer recommeds cessation of the use of machines which have experienced this fault. Units which have not experienced the fault may be used as normal. A software upgrade is planned.

Device

WATO EX-65 and A-Series (A5/A7) anaesthesia machines

Manufacturer

Mindray Medical Australia Pty Ltd