Recall of Radiometer TCM4 Transcutaneous Monitor

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
    13859
  • Event Initiated Date
    2012-12-04
  • Event Country
  • Event Source
    NZMMDSA
  • Event Source URL
  • 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
    There is a potential risk of receiving an electrical 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
    Product to be modified

Device

Manufacturer