# FDA recall Z-1755-2020

> **Radiometer Medical ApS** · Class II · device recall initiated 2020-02-20.

## 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.

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-1755-2020
- **Recalling firm:** Radiometer Medical ApS
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-20
- **Report date:** 2020-04-29
- **Termination date:** 2022-06-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bronshoj, N/A, Denmark

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1755-2020

## Citation

> AI Analytics. FDA recall Z-1755-2020. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1755-2020. Source: US FDA. Licensed CC0.

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