Events

Recall of Radiometer TCM5 transcutaneous 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-01416-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-11-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01416-1
  • 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 that part of the specifications stated in the tcm5 instructions for use (ifu) for professionals for tc sensor 92 is incorrect.The current ifu state incorrectly under “combined effects of linearity and hysteresis” the following:- at 33 % co2: better than 3 mmhg or 0.40 kpathe correct statement is:- at 33 % co2: better than 5 mmhg or 0.67 kpa.The above correction is not considered to be of clinical significance.
  • Action
    Radiometer is currently updating the Instructions for use and will distribute the updated version to customers when available. In the interim, users are notified of the update through the customer letter. This action has been closed-out on 23/06/2017. This action has been closed-out on 23/06/2017.

Device

Radiometer TCM5 transcutaneous blood gas monitor

Manufacturer

Radiometer Pacific Pty Ltd