System: Alphenix 4D CT in combination with CAS-930A — Class II medical device recall Z-1289-2022
Ongoing recall by Canon Medical System, USA, INC., reported 2022-07-06, distributed in CA, CO, FL, NY, WY. CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop
| Recall number | Z-1289-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Canon Medical System, USA, INC., Tustin, CA, United States |
| Recall initiated | 2022-05-03 |
| Classified | 2022-06-24 |
| Reported by FDA | 2022-07-06 |
| Distributed | CA, CO, FL, NY, WY |
| Quantity | 6 systems |
| UPC / GTIN / UDI-DI | 04987670100192 |
| Serial numbers | 30038795, 30039730, 30039787, 30043325, 30052648, BFA18Y7001, BHA1992001, BHB2132002, BHB2132003, BHC21X2004, SWB2162001 |
| Model numbers | INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW |
Product
System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
Reason for recall
CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated.
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-1289-2022. 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.