Events

Recall of Runyes Autoclave17L, 22L B Class Manufactured between 2012 & 2017

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medical Equipment 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-2018-RN-00001-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-01-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00001-1
  • 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
    Medical equipment australia has been made aware of an issue regarding the failure of cycles when the negative pressure is not within a specified range. affected devices will be provided with a software update to rectify the issue of monitoring critical parameters during a cycle and generate a 'fail' if they are not reached.
  • Action
    Medical Equipment Australia will arrange a service technician to be in contact with users to arrange for software upgrade to correct this issue. In the interim, users should refer to the tests outlined in the customer letter to verify that their equipment is functioning correctly.

Device

Runyes Autoclave17L, 22L B Class Manufactured between 2012 & 2017
  • Model / Serial
    Runyes Autoclave17L, 22L B ClassManufactured between 2012 & 2017Multiple Affected Serial NumbersARTG Number: 197900 (Medical Equipment Australia Pty Ltd - Sterilizer, moist heat, fluid)
  • Manufacturer
    Medical Equipment Australia Pty Ltd

Manufacturer

Medical Equipment Australia Pty Ltd