Radiometer Medical ApS recalls TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-…

Recall date

February 20, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1755-2020

FDA classification

Class II

Brand / firm

Radiometer Medical ApS

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.