- Recalling firm
- Canon Medical System, USA, INC.
- 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.
- Affected products (lot / model / serial)
- 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
- Units affected
- 10 systems
- Distribution pattern
- U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX.
- Firm location
- Tustin, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3014-2026
- Recall initiated
- August 4, 2026
- FDA classification date
- August 25, 2026
- FDA report date
- September 2, 2026
- FDA event ID
- 99222
- Last updated on HTM Vibe
- September 8, 2026