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Terminated

TCM CombiM Modules 903-111

FDA Recall Z-1595-2016 · Posted None

Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeLKD
Date Initiated2015-11-18
Date Terminated2018-03-27
Product Quantity1488

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093154TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEMRadiometer Medical Aps · 2010-02-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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