FDA Medical Device Recalls (openFDA)
Canon Medical System, USA, INC.: INFX-8000V. For radiographic and fluoroscopic studies and intervention.
- Recall number
- Z-1666-2022
- Recalling firm
- Canon Medical System, USA, INC.
- Product
- INFX-8000V. For radiographic and fluoroscopic studies and intervention.
- Status
- Open, Classified
- Initiated
- 2022-01-31
- Posted
- not on file
- Terminated
- not on file
- Reason
- The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
- Root cause
- Software design
- Action
- Canon sent an Urgent Electronic Product Radiation Warning letter dated July 28, 2022 to customers. . Customer were informed that in the interim a temporary countermeasure will be performed until such time as the software becomes available. A representative of Canon Medical Systems USA will contact you to schedule a time to install the countermeasure and at a later date, the updated software to address the issue. For scheduling questions, please contact our InTouch team at intouchdispatch@us.medical.canon. For questions call 800-421-1968 or your Canon service representative at 800.521.1968.
- Quantity
- 16 systems
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Model: Alphenix i with software version 8.0, 9.0 or 9.2 and the TFP 1200C FPD.
- 510(k) numbers
- ["K170909"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 2020563
- Firm city
- Tustin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28