Company: Radiometer Medical ApS
Date of Enforcement Report: 4/29/2020
Class II
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.
Recall Number: Z-1755-2020
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/MANUFACTURER
Radiometer Medical ApS on 2/20/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
84 units
DISTRIBUTION
US Nationwide and International