# FDA recall Z-1289-2022

> **Canon Medical System, USA, INC.** · Class II · device recall initiated 2022-05-03.

## 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.

## Distribution

U.S.: CA, CO, FL, NY, and WY  O.U.S.: None

## Key facts

- **Recall number:** Z-1289-2022
- **Recalling firm:** Canon Medical System, USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-05-03
- **Report date:** 2022-07-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tustin, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1289-2022

## Citation

> AI Analytics. FDA recall Z-1289-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1289-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*