Recall Z-1755-2020 ยท LKD Monitor, Carbon-Dioxide, Cutaneous
Radiometer Medical ApS
TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) - Product Usage: It is indicated for use on pediatrics and adults.
| Date | Feb 20, 2020 |
| Status | Terminated |
| Reason | Reports have been received about the transcutaneous monitoring system display flickering or monitor becoming non responsive and beeping. This may result in delayed patient monitoring as well as potentially compromise the product performance. |
| Root cause | Under Investigation by firm |
| Action | On February 20, 2020, a "Urgent: Medical device Recall" letter was sent to affected consignees via E-Mail and FedEx 2nd day delivery. In addition to informing consignees about the recall, the customer notification asked customers to take the following actions: 1. Cease using the affected TCM4 Base unit and put it on quarantine. 2. Complete the Recall Response Form (last page of this letter) and submit to your Radiometer representative. 3. Your Radiometer representative will exchange the computer hardware of your TCM4 Base unit as soon as possible when we receive replacement components. 4. If |
| Quantity | 84 units |
| Distribution | Worldwide distribution - US Nationwide distribution including the states of FL, KS, NY, ND, IN, TX, CA , VA, MA, MN, WI, IN, CT, WA and the countries of China, India, Japan, south Korea. |
| FDA record | Open on fda.gov |