INFX-8000V — Class II medical device recall Z-1666-2022
Ongoing recall by Canon Medical System, USA, INC., reported 2022-09-07, distributed nationwide. The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
| Recall number | Z-1666-2022 |
|---|---|
| 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 | 2022-01-31 |
| Classified | 2022-09-01 |
| Reported by FDA | 2022-09-07 |
| Distributed | Nationwide (US) |
| Quantity | 16 systems |
Product
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Reason for recall
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
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-1666-2022. 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.