epoc Host 2 as follows: Product SMN epoc NXS Host — Class II medical device recall Z-1215-2023
Ongoing recall by Siemens Healthcare Diagnostics Inc, reported 2023-03-15, distributed nationwide. pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure
| Recall number | Z-1215-2023 |
|---|---|
| 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 | 2022-12-12 |
| Classified | 2023-03-03 |
| Reported by FDA | 2023-03-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BO, 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, IR, IS, IT, JO, JP, KE, KR, KW, LT, LU, LV, MX, MY, NL, NO, NZ, PE, PH, PL, PT, QA, RO, SE, SG, SI, SK, TH, TN, TR, TW, UA, UY, VN, ZA |
| Quantity | 4,369 units |
| UPC / GTIN / UDI-DI | 00630414605678, 00630414605760, 00630414605814, 00630414605821, 00630414606095, 00630414612447 |
Product
epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 11413583
Reason for recall
pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure
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-1215-2023. 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.