# FDA recall Z-3014-2026

> **Canon Medical System, USA, INC.** · Class II · device recall initiated 2026-08-04.

## Product

Alphenix Models  INFX-8000C  INFX-8000F  INFX-8000V    This device is a digital radiography/fluoroscopy system used in a diagnostic and  interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

## Reason for recall

Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.

## Distribution

U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX.

## Key facts

- **Recall number:** Z-3014-2026
- **Recalling firm:** Canon Medical System, USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-08-04
- **Report date:** 2026-09-02

- **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-3014-2026

## Citation

> MORVS. FDA recall Z-3014-2026. Retrieved 2026-10-19 from https://api.morvs.ai/recall/Z-3014-2026. Source: US FDA. Licensed CC0.

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