Events

Recall of Radiometer TCM5 Flex Monitor (non-invasive blood gas monitor)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Radiometer Pacific 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-01264-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01264-1
  • 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
    Radiometer has recently become aware of a potential risk that the tcm5 monitor may not be compliant with the waterproof specification, ipx2, which is required for a homecare environment. the problem is caused by incorrect assembly and may allow water to enter into the monitor, which may pose a risk of electrical shock for the user. there have been no reports of injuries as a result of this issue.
  • Action
    Radiometer is advising users to stop use of the affected devices until they have been inspected and repaired where required by a Radiometer representative. A loan unit will be provided while the device is being repaired. This action has been closed-out on 17/05/2017.

Device

Radiometer TCM5 Flex Monitor (non-invasive blood gas monitor)
  • Model / Serial
    Radiometer TCM5 Flex Monitor (non-invasive blood gas monitor)Serial Numbers: below 393-500R0030N009ARTG Number: 140333
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd