TCM4 series Base Units — Class II medical device recall Z-1930-2013
Terminated recall by Radiometer America Inc, reported 2013-08-14, distributed nationwide. RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.
| Recall number | Z-1930-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer America Inc, Westlake, OH, United States |
| Recall initiated | 2012-11-27 |
| Classified | 2013-08-08 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2014-06-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 5,874 units |
| Serial numbers | 154R0002N002, 154R0004N003, 154R0004N008, 154R0005N004, 154R0005N005, 154R0005N005-U, 154R0005N006-154R0005N006, 154R0006N005, 154R0006N006, 154R0006N008-154R0006N010, 154R0007N001-154R0007N010, 154R0008N001, 154R0008N002, 154R0008N002U, 154R0008N003, 154R0008N005-154R0008N010, 154R0009N004, 154R0009N010, 154R0011N003, 154R0011N006-154R0011N009, 154R0012N001-154R0012N003, 154R0013N004, 154R0013N005, 154R0013N007-154R0013N010, 154R0014N009 and 475 more |
| Model numbers | 910-246 |
Product
TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.
Reason for recall
RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.
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-1930-2013. 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.