Events

Recall of Radiometer TCM5 FLEX/ BASIC Transcutaneous 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-2018-RN-00299-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-04-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00299-1
  • 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 previously informed users that they had received reports that instruments sensitive to electromagnetic interference may be affected by tcm5 measurements (tga ref: rc-2018-rn-00081-1 and rc-2017-rn-01327-1).Radiometer has released the revised version of the instructions for use which includes a separate paragraph in the introduction section under “electromagnetic interference”. this amendment is included from the tcm5 instructions for use, 996-436, version 201801f, pages 5 and 6. the updated ifu mirror the actions for users identified in rc-2018-rn-00081-1.
  • Action
    Radiometer is advising users to discard previous revisions of the Instructions for Use and replace these with the new versions. Radiometer is working on a solution, which involves a hardware redesign of the TCM5 monitoring system, for this issue. Users will be contacted by their Radiometer representative when the final solution is available.

Device

Radiometer TCM5 FLEX/ BASIC Transcutaneous Monitor
  • Model / Serial
    Radiometer TCM5 FLEX/ BASIC Transcutaneous MonitorAll Serial NumbersARTG Number: 140333(Radiometer Pacific - Transcutaneous blood gas monitor)
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd