TCM CombiM Modules 903-111 — Class II medical device recall Z-1595-2016
Terminated recall by Radiometer America Inc, reported 2016-05-11, distributed nationwide. Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that can cause the a
| Recall number | Z-1595-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer America Inc, Brea, CA, United States |
| Recall initiated | 2015-11-18 |
| Classified | 2016-05-02 |
| Reported by FDA | 2016-05-11 |
| Terminated | 2018-03-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BR, CA, CN, CZ, DE, DK, ES, FI, FR, GB, HK, HN, HR, HU, IE, IL, IN, IS, IT, JO, KE, KR, KW, MT, MX, NL, NO, NZ, OM, PE, PH, PL, QA, RO, RU, SA, SE, SG, TH, TR, TW, ZA |
| Quantity | 1,488 |
| Model numbers | 903-111 |
Product
TCM CombiM Modules 903-111
Reason for recall
Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that can cause the alarm to sound higher than the pre-set maximum volume.
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-1595-2016. 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.