Events

Recall of TCM40 MONITORING SYSTEM - TCM4 SERIES MKII 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
    71828
  • Event Risk Class
    II
  • Event Initiated Date
    2006-06-20
  • 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
    A recall in canada was not necessary since the devices were fixed prior to installation in canada.

Device

TCM40 MONITORING SYSTEM - TCM4 SERIES MKII BASE UNIT
  • Model / Serial
    Model Catalog: 391-876 (Lot serial: R0036 to R0043)
  • Product Description
    TCM40 Monitor - TCM4 Series MKII Base
  • Manufacturer
    RADIOMETER MEDICAL APS

Manufacturer

RADIOMETER MEDICAL APS