Recall Z-1755-2020— Radiometer Medical ApS
Class II · Terminated
Class II FDA medical device recall by Radiometer Medical ApS, initiated 2020-02-20, terminated 2022-06-24. It names 3 FDA 510(k) clearances: K093154, K043003, K001866. Product: 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.. 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..
- Recalling firm
- Radiometer Medical ApS
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-20
- Terminated
- 2022-06-24
- Firm location
- Bronshoj, N/A, Denmark
510(k) clearances named in this recall
3 on FDA's record- K093154 — TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM
- K043003 — TCM40 MONITORING SYSTEM
- K001866 — TCM400
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.