Reported Sep 2, 2026 · Ongoing · Updated Sep 7, 2026
Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a…
Canon Medical System, USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Canon Medical System, USA, INC. · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
- 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.
- Lot codes and dates
7 of 7 products
Products covered by this recall Model / number Product as published INFX-8000C/B3UDI code: Pending SID Number:30101165 Serial Number: B3E2422005 INFX-8000F/SGUDI code: Pending SID Number: 30093711 Serial Number: SGC2412001 INFX-8000V/SZUDI code: Pending SID Number: 30029686 Serial Number: SZA2422001 SID Number: 79000002 Serial Number:SZA2442004 INFX-8000V/SXUDI code: Pending SID Number: 30049491 Serial Number: SXA2432001 SID Number: 30100053 Serial Number: SXA2432002 INFX-8000V/B9UDI code: Pending SID Number: 30059175 Serial Number: B9F2412001 INFX-8000V/STUDI code: Pending SID Number: 30059180 Serial Number: STA2412001 INFX-8000V/SZUDI code: Pending SID Number: 30095017 Serial Number: SZA2432003 SID Number: 30097052 Serial Number: SZA2422002 - Amount recalled
- 10 systems
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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