epoc NXS Host Blood Analysis System — Class II medical device recall Z-0601-2024
Ongoing recall by Siemens Healthcare Diagnostics Inc, reported 2023-12-27, distributed nationwide. Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions,
| Recall number | Z-0601-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics Inc, Norwood, MA, United States |
| Recall initiated | 2023-10-19 |
| Classified | 2023-12-20 |
| Reported by FDA | 2023-12-27 |
| Distributed | Nationwide (US) |
| Quantity | 10,183 devices |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00630414605678, 00630414605760, 00630414605814, 00630414605821, 00630414605838, 00630414606095, 00630414612447, 00630414631028 |
Product
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11
Reason for recall
Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run on the epoc NXS Host and Delete Blood Tests feature is enabled, the results that are generated at the time of testing are correct; however, when this issue occurs, results that are printed, saved and/or transferred to a data manager, may include unselected analytes that are from a previous patient or QC test. The worst possible outcome may result in a failure to diagnose hyperkalemia, due to an erroneous depressed potassium level or inappropriate treatment to hyperglycemia due to erroneous glucose reading.
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-0601-2024. 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.