Events

Recall of Transcutaneous blood gas monitor

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

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
    22316
  • Event Initiated Date
    2018-01-25
  • 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
    The manufacturer has recently received reports of occurrences of the tcm5 causing interferences on ecg and eeg monitors., there is a possibility that tcm5 flex/basic can cause interferences to ecg or eeg measurements, however, only when applied on the same patient. this situation only affects customers who use the tcm5 flex/basic in combination with an ecg or eeg measurement on a patient., latest updated recall action, the manufacturer is advising that other instruments sensitive to electromagnetic interference may be affected by the tc measurement. in a worst-case scenario, the described error may result in insufficient or no treatment for a critically low heart rate or critical arrhythmias.
  • Action
    Instructions for use to be updated

Device

Transcutaneous blood gas monitor
  • Model / Serial
    Model: , Affected: Product code TCM5FLEX/BASIC
  • Manufacturer
    Radiometer Basel AG

Manufacturer

Radiometer Basel AG