Events

Recall of TCM TOSCA/COMBIM MONITORING SYSTEM - TCM COMBIM MODULE

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
    69528
  • Event Risk Class
    II
  • Event Initiated Date
    2015-11-18
  • 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
    After running without any problems and with the volume control set to 1 the analyzer gave an alarm which was significantly louder than the specified highest possible level.

Device

TCM TOSCA/COMBIM MONITORING SYSTEM - TCM COMBIM MODULE
  • Model / Serial
    Model Catalog: 903-111 (Lot serial: >10. Contact mfg)
  • Product Description
    TCM COMBI M MODULES
  • Manufacturer
    RADIOMETER MEDICAL APS

Manufacturer

RADIOMETER MEDICAL APS