Recall archive / FDA device enforcement
Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a di... — FDA record Z-3014-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 4, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- 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
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 10 systems
- Agency-reported status
- Ongoing
- Source record identifier
- Z-3014-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 2, 2026
- Recall initiation date
- Aug 4, 2026
- Center classification date
- Aug 25, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.