System INFX-8000C — Class II medical device recall Z-1175-2021
Ongoing recall by Canon Medical System, USA, INC., reported 2021-03-17, distributed nationwide. The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some
| Recall number | Z-1175-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Canon Medical System, USA, INC., Tustin, CA, United States |
| Recall initiated | 2021-02-05 |
| Classified | 2021-03-09 |
| Reported by FDA | 2021-03-17 |
| Distributed | Nationwide (US) |
| Quantity | 272 in |
| Model numbers | CAS-830B, CAS-880A |
Product
System INFX-8000C
Reason for recall
The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
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-1175-2021. 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.