epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2 — Class II medical device recall Z-1214-2023
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-1214-2023 |
|---|---|
| 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 | 22,156 units |
| UPC / GTIN / UDI-DI | 00630414606378, 00630414606460, 00630414608532, 00630414608617, 00630414608624, 00630414614762, 00630414614885, 00630414614892, 00630414615004, 00809708052898, 00809708053901, 00809708069117, 00809708069124, 00809708075576, 00809708075583, 00809708097219, 00809708097226 |
| Model numbers | 00630414614885, 11413602 |
Product
epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished 10736395 epoc Host 2, Chinese, Refurbished 10736433 epoc Host 2, US (MC55X) 11413524 epoc Host 2, ROW (MC55X) 11413528 epoc Host 2, India (MC55X) 11413541 epoc Host 2, China (MC55X) 11413542 epoc Host 2, Japan (MC55X) 11413543 epoc Host 2 (MC55X) - US - Refurbished 11413601 "epoc Host 2 (MC55X) - ROW -Refurbished" 11413602 epoc Host 2 (MC55X) - India - Refurbished 11413603 epoc Host 2 (MC55X) - Japan - Refurbished 11413604
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-1214-2023. 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.