Class IIDeviceOngoing

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 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.

Details

Recall number: Z-3014-2026
Event ID: 99222
Recall initiated: Aug 4, 2026
Classified: Aug 25, 2026
Reported: Sep 2, 2026
Quantity: 10 systems
Distribution: U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Tustin, CA, United States
Lot / code info: Model Number: INFX-8000C/B3 UDI code: Pending SID Number:30101165 Serial Number: B3E2422005 Model Number: INFX-8000F/SG UDI code: Pending SID Number: 30093711 Serial Number: SGC2412001 Model Number: INFX-8000V/SZ UDI code: Pending SID Number: 30029686 Serial Number: SZA2422001 SID Number: 79000002 Serial Number:SZA2442004 Model Number: INFX-8000V/SX UDI code: Pending SID Number: 30049491 Serial Number: SXA2432001 SID Number: 30100053 Serial Number: SXA2432002 Model Number: INFX-8000V/B9 UDI code: Pending SID Number: 30059175 Serial Number: B9F2412001 Model Number: INFX-8000V/ST UDI code: Pending SID Number: 30059180 Serial Number: STA2412001 Model Number: INFX-8000V/SZ UDI code: Pending SID Number: 30095017 Serial Number: SZA2432003 SID Number: 30097052 Serial Number: SZA2422002