Events

Recall of TCM CombiM module (used with Radiometer Transcutaneous Monitors)

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-2015-RN-01200-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01200-1
  • 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 tcm combi m modules with a serial number below 903-111r0174nxxx* may, on rare occasions, have an error that will cause the alarm sound to be higher than the pre-set maximum volume.If the alarm sound is higher than the pre-set volume then critically ill premature infants may experience a critical stress reaction if the tcm combi m monitor is placed close to the infant and the too high alarm is not silenced.
  • Action
    Radiometer is advising users with devices in Newborn or NICU units to turn off the monitor and contact Radiometer if the error occurs. Radiometer will be replacing all units which are used in these areas. Radiometer is providing a warning label to be placed on all TCM4 units which are not used in the Newborn or NICU units, and to advise Radiometer if the error occurs. This action has been closed-out on 31/08/2016.

Device

TCM CombiM module (used with Radiometer Transcutaneous Monitors)
  • Model / Serial
    TCM CombiM module (used with Radiometer Transcutaneous Monitors)Product Code: 903-111Affected Serial Numbers: below 903-111R0174Nxxx ARTG Number:167226
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd