RAPIDPoint¿ 500 Blood Gas Analyzer with v2 — Class II medical device recall Z-2040-2017
Terminated recall by Siemens Healthcare Diagnostics Inc, reported 2017-05-17, distributed nationwide. Potential Patient Demographic Error with Blank Patient ID Field
| Recall number | Z-2040-2017 |
|---|---|
| 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 | 2017-04-10 |
| Classified | 2017-05-05 |
| Reported by FDA | 2017-05-17 |
| Terminated | 2019-08-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BD, CH, CL, CO, DE, ES, FR, HK, IE, IN, JP, LV, MX, TH, UY |
| Quantity | 159 units |
| Serial numbers | 30762, 30779, 30784, 30819, 30841, 30842, 30844, 30846, 30904, 30905, 30906, 30907, 31006, 313388, 31771, 31772, 32356, 32470, 33198, 33201, 33232, 33370, 33438, 33459, 33573 and 134 more |
Product
RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. Siemens SMN numbers: 10492730, 10696857, 10697306
Reason for recall
Potential Patient Demographic Error with Blank Patient ID Field
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-2040-2017. 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.