Canon Medical System, Usa, Inc.: Alphenix Models Infx-8000c Infx-8000f Infx-8000v This Device Is A Digital Radiography/fluoroscopy System Used In A Diagnostic And Interventional An...
Canon Medical Alphenix Recall Summary Canon Medical System's Alphenix digital X-ray systems (models INFX-8000C, INFX-8000F, and INFX-8000V) are being recalled because fixing screws on the ceiling-mounted arm may become loose. These systems are used in hospitals for diagnostic imaging and angiography procedures to examine blood vessels in the heart, brain, abdomen, and legs. The recall affects facilities nationwide, particularly 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
- U.S. Food and Drug Administration
- Recall date
- 2026-08-04
- Status
- Ongoing
- 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 U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/be3b2802-01f2-4026-a287-ebb87b9fca06