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Class 2 Device Recall The TCM CombiM monitoring system |
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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
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Product Classification |
Monitor, carbon-dioxide, cutaneous - Product Code LKD
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Product |
TCM CombiM Modules 903-111 |
Code Information |
Part Number: 903-111 Lot Number: Below R0174 |
Recalling Firm/ Manufacturer |
Radiometer America Inc 250 S Kraemer Blvd Brea CA 92821-6232
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For Additional Information Contact |
Radiometer America Technical Support 440-871-8900
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = LKD and Original Applicant = RADIOMETER MEDICAL APS
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