FDA-Device2026-09-02Class IIPROCESSING DEFECT
Canon Medical Alphenix X-ray systems recalled for loose ceiling arm screws
What this means
Fixing screws on the ceiling movement gear of the suspended arm in Canon Medical Alphenix interventional X-ray systems may become loose over time. This could potentially cause the arm to shift during use. Ten systems are affected across eight U.S. states.
- If you operate or maintain one of these systems, contact Canon Medical System, USA, INC. for inspection and repair instructions.
- Do not use the system if you notice any movement or instability in the ceiling-suspended arm.
- Check your system's model number and serial number against the recall list to confirm if your equipment is affected.
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX.
Affected count
10 systems
Manufactured in
2441 Michelle Dr, N/A, Tustin, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3014-2026Want us to check the next one for you?
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