FDA recall Z-3014-2026

Canon Medical System, USA, INC. · Class II · device

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

Status
Ongoing
Initiation date
2026-08-04
Report date
2026-09-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tustin, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3014-2026