Events

Recall of Radiometer TCM CombiM module

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Radiometer Medical ApS.

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
    19537
  • Event Initiated Date
    2015-12-08
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Radiometer Pacific, Unit 3, 33 Spartan Road, Takanini 2105
  • Reason
    Radiometer has 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.
  • Action
    Product to be exchanged

Device

Radiometer TCM CombiM module
  • Model / Serial
    Model: 903-111, Affected: Serial numbers below: 903-911R0174Nxxx
  • Manufacturer
    Radiometer Medical ApS

Manufacturer

Radiometer Medical ApS