Events

Recall of Device Recall The TCM CombiM monitoring system

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    73601
  • Event Risk Class
    Class 2
  • Event Number
    Z-1595-2016
  • Event Initiated Date
    2015-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-03-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144559
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Monitor, carbon-dioxide, cutaneous - Product Code LKD
  • Reason
    Radiometer america, inc. is recalling tcm combim on rare occasions they may have an error that can cause the alarm to sound higher than the pre-set maximum volume.
  • Action
    RadioMeter sent an Product Notification letter out on November 18, 2015, January 10, 2016 and March 29, 2016. The notification sent on November 18, 2015 and January 10, 2016, instructed customers a temporary solution of switching off the analyzer and then on again in order to re-establish the pre-set alarm volume. If alarm sound is higher than the pre-set volume customers are instructed to contact their local Radiometer service representative. If any questions contact Radiometer America Technical Support at 1-800-736--600 opt. 4. The notification sent on March 29, 2016, provided the same instructions and temporary solution. The notification also informed customers that the firm will be in contact with them to discuss the upgrade process.

Device

Device Recall The TCM CombiM monitoring system
  • Model / Serial
    Part Number: 903-111 Lot Number: Below R0174
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution to the states of : MO, NE, AL, PA, IL, MN, TX, ID, CO, UT, NV, CA, NY, RI, OR, NJ, AZ, GA, IN, VA, LA, NM, MD and AR., and to the countries of : Canada, Austria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, United Kingdom, Italy, Netherlands, Norway, Spain, Sweden, United Arab Emirates, Kuwait, Qatar, Saudi Arabia, Oman, Jordan, Croatia, Malta, Iceland, Brazil, Thailand, Philippines, Peru, Honduras, Mexico, Kenya, Israel, Romania, Russia, Poland, Turkey, Australia, New Zealand, China, Hong Kong, South Africa, India, Korea, Singapore and Taiwan.
  • Product Description
    TCM CombiM || Modules 903-111
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Manufacturer Address
    Radiometer America Inc, 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA