Recall Z-1595-2016 ยท LKD Monitor, Carbon-Dioxide, Cutaneous
Radiometer America Inc
TCM CombiM Modules 903-111
| Date | Nov 18, 2015 |
| Status | Terminated |
| 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. |
| Root cause | 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 |
| Quantity | 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 Kingd |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093154 | TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM Radiometer Medical Aps, Feb 5, 2010 |