CLASS II ONGOING Device recall · Reported 6 Jul 2022 · FDA Enforcement Report

System: Alphenix 4D CT in combination with CAS-930A (C arm Support) recalled

Canon Medical System USA is recalling System: Alphenix 4D CT in combination with CAS-930A (C arm Support), distributed in California, Colorado, Florida, New York, Wyoming. The recall was initiated on 3 May 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI Code: 04987670100192 Model Number: INFX-8000C/BF Serial Number/SID: BFA18Y7001 / 30038795 Model Number: INFX-8000C/BH Serial Number / SID: BHB2132002 / 30039730 BHB2132003/ 30039787 BHA1992001 / 30043325 BHC21X2004 / Not Provided Model Number: INFX-8000C/SW Serial Numbers/SID: SWB2162001 / 30052648

Quantity recalled6 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-1289-2022
FDA event ID: 90246
Recalling firm: Canon Medical System USA, Tustin, CA
Classification: Class II
Status: Ongoing
Recall initiated: 3 May 2022
FDA classified: 24 Jun 2022
Reported: 6 Jul 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

3 May 2022	Recall initiated by company
24 Jun 2022	Classified by FDA	+52 days
6 Jul 2022	Published in enforcement report	+12 days

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

Reason for recall

CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated.

Product as listed by the FDA

System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW

Where it was distributed

U.S.: CA, CO, FL, NY, and WY O.U.S.: None

California Colorado Florida New York Wyoming

Questions about this recall

Why was it recalled?

CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated.

Which lots are affected?

UDI-DI Code: 04987670100192 Model Number: INFX-8000C/BF Serial Number/SID: BFA18Y7001 / 30038795 Model Number: INFX-8000C/BH Serial Number / SID: BHB2132002 / 30039730 BHB2132003/ 30039787 BHA1992001 / 30043325 BHC21X2004 / Not Provided Model Number: INFX-8000C/SW Serial Numbers/SID: SWB2162001 / 30052648

Where was it sold?

U.S.: CA, CO, FL, NY, and WY O.U.S.: None

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
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled	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

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