Events

Recall of Radiometer TCM4 series analyser base units (Transcutaneous and non invasive blood gas analysers)

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-2012-RN-01207-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-12-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01207-1
  • 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 become aware that specified tcm4 series base units do not comply with the medical safety standard iec 60601-1, 2nd edition, subclause 15(b).The implication is that there is a potential risk of receiving an electric shock under certain conditions as follows:the monitor is connected to the mains outlet and the mains switch is on; the battery is fully charged (or no battery is present); the operator disconnects the line cord (at either end) without first switching the mains switch on the back of the monitor to off; the operator touches the two metal pins on the mains plug or on the monitor's line cord receptacle after disconnecting the line cord.
  • Action
    Radiometer is informing users of the issue and is providing fluorescent warning stickers to be placed on the device and work around instructions to mitigate the risk if the device must be used. A hardware correction is forthcoming to permanently correct the problem.

Device

Radiometer TCM4 series analyser base units (Transcutaneous and non invasive blood gas analysers)
  • Model / Serial
    Radiometer TCM4 series analyser base units (Transcutaneous and non invasive blood gas analysers)Multiple item numbers and serial numbersARTG Numbers: 119074, 133015 & 133014
  • Product Classification
    Anesthesiology Devices
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd