Events

Recall of Radiometer TCM5FLEX/BASICAll

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-00297-1
  • Event Risk Class
    Class III
  • 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-00297-1
  • 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 the wi-fi hardware incorporated in the tcm5 monitor is not compliant with respect to the requirements for radiated emission (radio equipment directive 2014/53/eu).Australian customers do not currently utilise the wi-fi option on these devices.
  • Action
    Radiometer is advising that they will be contacting affected users to arrange for the software to be upgraded on TCM5 to V1.2.0 which will disable the Wi-Fi hardware. Customers have been supplied an updated IFU which removes reference to Wi-Fi as part of the correction undertaken for RC-2018-RN-00299-1

Device

Radiometer TCM5FLEX/BASICAll
  • Model / Serial
    Radiometer TCM5FLEX/BASICAll Serial NumbersARTG Number:140333(Radiometer Pacific - Transcutaneous blood gas monitor)
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd