Canon Medical System, Usa, Inc.: Interventional Fluoroscopic X-ray System
Recall Summary Canon Medical System is recalling certain Alphenix interventional fluoroscopic X-ray systems (models INFX-8000C, INFX-8000F, and INFX-8000V) used in hospitals for diagnostic imaging of blood vessels. The ceiling-suspended arm of these systems has fixing screws that may become loose, creating a potential safety hazard. The recall affects systems distributed across the U.S., primarily in California, Georgia, Minnesota, North Carolina, Nevada, Pennsylvania, Ohio, and Texas.
- Recalling firm
- Canon Medical System, USA, INC.
- 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
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-04
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/7613694d-814d-485c-8028-02c78580a04b