medical Class II Updated 2020-04-29

Radiometer Medical ApS recalls TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used wi

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Affected Serial Numbers: 391-880R0471N017, 391-880R0471N030, 391-880R0473N006, 391-880R0473N016, 391-880R0471N021, 391-880R0472N010, 391-880R0473N007, 391-880R0471N022, 391-880R0472N011, 391-880R0473N008, 391-880R0471N023, 391-880R0472N014, 391-880R0473N009, 391-880R0471N024, 391-880R0472N016, 391-880R0473N010, 391-880R0471N025, 391-880R0472N020, 391-880R0473N011, 391-880R0471N026, 391-880R0473N001, 391-880R0473N020, 391-880R0471N027, 391-880R0473N002, 391-880R0473N013, 391-880R0471N028, 391-880R0473N003, 391-880R0473N014, 391-880R0471N029, 391-880R0473N005, 391-880R0473N015,
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