Radiometer Medical ApS: Medical Device Recall in 2020 - (Recall #: Z-1755-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 20, 2020

Date Posted: April 29, 2020

Recall Number: Z-1755-2020

Event ID: 85257

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.

Status: Terminated

Product Quantity: 84 units

Code Information:

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,

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated