Recall archive / FDA device enforcement
System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-... — FDA record Z-1289-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 3, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- 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.
- Classification
- Class II
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 6 systems
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1289-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI Code: 04987670100192 Model Number: INFX-8000C/BF Serial Number/SID: BFA18Y7001 / 30038795 Model Number: INFX-8000C/BH Serial Number / SID: BHB2132002 / 30039730 BHB2132003/ 30039787 BHA1992001 / 30043325 BHC21X2004 / Not Provided Model Number: INFX-8000C/SW Serial Numbers/SID: SWB2162001 / 30052648 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.: CA, CO, FL, NY, and WY O.U.S.: None
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 6, 2022
- Recall initiation date
- May 3, 2022
- Center classification date
- Jun 24, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.