Surpria: Software Version V3 — Class II medical device recall Z-1749-2022
Ongoing recall by FUJIFILM Healthcare Americas Corporation, reported 2022-09-21, distributed nationwide. Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Ra
| Recall number | Z-1749-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | FUJIFILM Healthcare Americas Corporation, Lexington, MA, United States |
| Recall initiated | 2022-07-12 |
| Classified | 2022-09-15 |
| Reported by FDA | 2022-09-21 |
| Distributed | Nationwide (US) |
| Quantity | 20 units |
| UPC / GTIN / UDI-DI | 04573596200520, 04580292766601 |
| Serial numbers | G1Z0040620, G1Z0048121, G1Z0063520, G1Z0083221, G1Z0094521, G1Z0094621, G1Z0115321, G1Z0123621, G1Z0190021, G1Z0190121, G1Z0190221, G1Z0190321, G1Z0210821, G1Z0210921, G1Z0211021, G1Z0244920, G560045319, G560048119, G560071519, G560075519 |
Product
Surpria: Software Version V3.11, V3.22
Reason for recall
Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation
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-1749-2022. 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.