CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report

Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled

Canon Medical System USA is recalling Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is a, distributed nationwide in the US. The recall was initiated on 4 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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

Quantity recalled10 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3014-2026
FDA event ID: 99222
Recalling firm: Canon Medical System USA, Tustin, CA
Classification: Class II
Status: Ongoing
Recall initiated: 4 Aug 2026
FDA classified: 25 Aug 2026
Reported: 2 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

4 Aug 2026	Recall initiated by company
25 Aug 2026	Classified by FDA	+21 days
2 Sep 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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 as listed by the FDA

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.

Where it was distributed

U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX.

Nationwide California Georgia Minnesota North Carolina Nevada Ohio Pennsylvania Texas

Questions about this recall

Why was it 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.

Which lots are affected?

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

Where was it sold?

U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Canon Medical System USA

All 51

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Alphenix Infx-8000C/B5 recalled by Canon Medical System USA	Canon Medical System USA	Other	Nationwide
4 Feb 2026Device	CLASS II	Alphenix Infx-8000C, interventional fluoroscopic x-ray system recalled	Canon Medical System USA	Device Malfunction	Nationwide
4 Feb 2026Device	CLASS II	Alphenix Infx-8000V, interventional fluoroscopic x-ray system recalled	Canon Medical System USA	Device Malfunction	Nationwide
4 Feb 2026Device	CLASS II	Alphenix Infx-8000H, interventional fluoroscopic x-ray system recalled	Canon Medical System USA	Device Malfunction	Nationwide
4 Feb 2026Device	CLASS II	Alphenix Infx-8000F, interventional fluoroscopic x-ray system recalled	Canon Medical System USA	Device Malfunction	Nationwide

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