Events

Recall of TCM4 SYSTEM - BASE UNIT

According to Health Canada (via FOI), this recall involved a device in Canada 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
    119845
  • Event Risk Class
    II
  • Event Initiated Date
    2012-11-27
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    As reported to radiometer there is a potential risk of receiving an electrical shock under certain conditions. tcm4 series base unit does not comply eith iec 60601-1 2nd edition subclause 15(b).

Device

TCM4 SYSTEM - BASE UNIT
  • Model / Serial
    Model Catalog: POWER SUPPLY 910-246 (Lot serial: 910-246); Model Catalog: 391-876 (Lot serial: 000-154); Model Catalog: 391-880 (Lot serial: 910-246); Model Catalog: 391-878 (Lot serial: 910-246); Model Catalog: 391-876 (Lot serial: 910-246); Model Catalog: POWER SUPPLY 910-246 (Lot serial: serial # below R0175N009); Model Catalog: 000-154 (Lot serial: serial # below R0175N009); Model Catalog: 391-880 (Lot serial: serial # below R0175N009); Model Catalog: 391-878 (Lot serial: serial # below R0175N009); Model Catalog: 391-876 (Lot serial: serial # below R0175N009); Model Catalog: POWER SUPPLY 910-246 (Lot serial: 391-880); Model Catalog: 000-154 (Lot serial: 391-880); Model Catalog: 391-880 (Lot serial: 391-880); Model Catalog: 391-878 (Lot serial: 391-880); Model Catalog: 391-876 (Lot serial: 391-880); Model Catalog: POWER SUPPLY 910-246 (Lot serial: 391-878); Model Catalog: 000-154 (Lot serial: 391-878); Model Catalog: 391-880 (Lot serial: 391-878); Model Catalog: 391-878 (Lot serial: 391-878); Model Catalo
  • Product Description
    TCM4 SERIES BASE UNIT
  • Manufacturer
    RADIOMETER MEDICAL APS

Manufacturer

RADIOMETER MEDICAL APS