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 indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
- Recall number
- Z-3014-2026
- Event id
- 99222
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Canon Medical System, USA, INC.
- Report date
- Sep 2, 2026
- Posted
- Aug 25, 2026
- Initiated
- Aug 4, 2026
- Center classification date
- Aug 25, 2026
- Product code
- OWB
- Device type
- Interventional Fluoroscopic X-Ray System
- 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.
- Root cause
- Process control
- Quantity
- 10 systems
- 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
- Distribution
- U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Tustin, CA, United States