Events

Recall of TCM40 MONITORING SYSTEM - TCPO2 ACCESSORY KIT (D826)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RADIOMETER AMERICA INC..

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
    42744
  • Event Risk Class
    II
  • Event Initiated Date
    2005-10-28
  • 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
    It has been found that membrane units of specified lots cause the electrode to exceed performance specifications for drift in the initial period (first two or more calibrations).

Device

TCM40 MONITORING SYSTEM - TCPO2 ACCESSORY KIT (D826)
  • Model / Serial
    Model Catalog: 904-308 (Lot serial: R0172 TO R0223 INCLUSIVE)
  • Product Description
    D826 ACCESSORY KIT
  • Manufacturer
    RADIOMETER AMERICA INC.

Manufacturer

RADIOMETER AMERICA INC.