Canon Medical System recall: Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital…
Canon Medical System, USA, INC. is recalling Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital… – 10 systems. The U.S. Food and Drug Administration published the recall on September 2, 2026; it began on August 4, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital… |
| Brand | Canon Medical System |
| Company | Canon Medical System, USA, INC. |
| Type | Medical devices |
| Classification | Class II |
| Recall date | August 4, 2026 |
| Published by FDA | September 2, 2026 |
| Quantity | 10 systems |
| Recall ID | 99222 |
Recalled products
- 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.
- FDA recall number
- Z-3014-2026
- Codes, lots and dates
- 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
- Quantity
- 10 systems
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99222
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Tustin, CA, United States
Why it was recalled
The reason the FDA lists: “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.”
Where it was sold
Nationwide. Distribution as the FDA records it: “U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99222, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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| Oct 7, 2026 | Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS) | The potential for falsely elevated results. Serious | FDA Class II |
| Oct 7, 2026 | Tandem Diabetes Care recall: T:slim Mobile ApplicationMedical devices · 177 | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a sof… Serious | FDA Class II |
About this recall
Is Canon Medical System Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital… recalled?
Yes. Canon Medical System, USA, INC. recalled it on August 4, 2026; FDA published it September 2, 2026 (Class II). Only the lots, dates or models listed on this page are included.
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.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.