TCM4 Base unit — Class II medical device recall Z-1755-2020
Terminated recall by Radiometer Medical ApS, reported 2020-04-29, distributed nationwide. Reports have been received about the transcutaneous monitoring system display flickering or monitor becoming n
| Recall number | Z-1755-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer Medical ApS, Bronshoj, N/A, Denmark |
| Recall initiated | 2020-02-20 |
| Classified | 2020-04-22 |
| Reported by FDA | 2020-04-29 |
| Terminated | 2022-06-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, IN, JP, KR |
| Quantity | 84 units |
| UPC / GTIN / UDI-DI | 05700693918808 |
| Serial numbers | 391-880R0471N017, 391-880R0471N021, 391-880R0471N022, 391-880R0471N023, 391-880R0471N024, 391-880R0471N025, 391-880R0471N026, 391-880R0471N027, 391-880R0471N028, 391-880R0471N029, 391-880R0471N030, 391-880R0472N010, 391-880R0472N011, 391-880R0472N014, 391-880R0472N016, 391-880R0472N020, 391-880R0473N001, 391-880R0473N002, 391-880R0473N003, 391-880R0473N005, 391-880R0473N006, 391-880R0473N007, 391-880R0473N008, 391-880R0473N009, 391-880R0473N010 and 6 more |
| Model numbers | 391-880 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1755-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.