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 Insight

This FDA Devices action (record #Z-1755-2020) was formally reported on April 29, 2020, with the manufacturer initiating the action on February 20, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Radiometer Medical ApS is listed as the recalling firm, operating out of Bronshoj, N/A. Federal records list the affected scope as 84 units.

The documented reason for this recall is: 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 th… Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.