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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 int

Medical DevicesSource: FDA (device) · Date: 2026-09-02

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
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 / hazard
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
Status
Ongoing
Distribution / sold at
U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX.
Recall initiated
2026-08-04
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
Product quantity
10 systems
Voluntary mandated
Voluntary: Firm initiated
City
Tustin
State
CA
Country
United States
Event id
99222
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