Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number — Class II medical device recall Z-2797-2016
Terminated recall by Siemens Healthcare Diagnostics Inc, reported 2016-09-21, distributed nationwide. There is a potential for the first and/or last name of one patient to be printed with Patient ID and result da
| Recall number | Z-2797-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics Inc, Norwood, MA, United States |
| Recall initiated | 2016-08-11 |
| Classified | 2016-09-14 |
| Reported by FDA | 2016-09-21 |
| Terminated | 2020-07-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IS, IT, JP, KE, KR, KW, LB, LT, LU, LV, MX, MY, NL, NO, NZ, PE, PH, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, UY, VN, ZA |
| Quantity | 492 units |
Product
Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number (SMN): 10291507,10314585, 10318899,10321239,10322654,10324081, 10328803, 10331381 , 10339634
Reason for recall
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
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-2797-2016. 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.