Medical Device Recall: 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 indicat
Canon Medical System, USA, INC. · August 4, 2026
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.
Product Description
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.
Distribution
U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX.
States Affected
NATIONWIDE
Quantity Affected
10 systems
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3014-2026
Status: ongoing
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