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U.S. Department of Health and Human Services

Class 2 Device Recall The TCM CombiM monitoring system

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  Class 2 Device Recall The TCM CombiM monitoring system see related information
Date Initiated by Firm November 18, 2015
Create Date May 02, 2016
Recall Status1 Terminated 3 on March 27, 2018
Recall Number Z-1595-2016
Recall Event ID 73601
510(K)Number K093154  
Product Classification Monitor, carbon-dioxide, cutaneous - Product Code LKD
Product TCM CombiM
Modules 903-111
Code Information Part Number: 903-111 Lot Number: Below R0174
Recalling Firm/
Radiometer America Inc
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Radiometer America Technical Support
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Software design
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.
Quantity in Commerce 1488
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LKD and Original Applicant = RADIOMETER MEDICAL APS