FDA Medical Device Recalls (openFDA)
Canon Medical System, USA, INC.: System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
- Recall number
- Z-1289-2022
- Recalling firm
- Canon Medical System, USA, INC.
- Product
- System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
- Status
- Open, Classified
- Initiated
- 2022-05-03
- Posted
- 2022-06-24
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Software design
- Action
- On or about 04/20/2022, Canon Medical Systems USA, Inc sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter informing customer of a potential issue with your ALPHENIX System when used in combination with a CT system where the CT operations may be restricted by an interlock which is a result of an error "H29 M. Net error. The Error message(s) Gantry reached inner limit or Gantry reached out limit may be seen on the CT System at the time of occurence. The CT system may stop operating properly after an attempt to cancel the error message has been initiated. The error may result in the patient needing to be moved to another system for a repeat scan, which could cause a delay in diagnosis or decrease comfort for the patient. Customers are being informed that the Recalling Firm has developed a software update that will be installed by a representative of Canon Medical Systems USA that should correct the issue/situation. Prior to the install of the software update, the Urgent customer letter provides a Error resetting (workaround) as follows: 1. Hold down the Anatomical angle control selection button and the Override button on the tableside console or the satellite console (option) simultaneously for at least 1 second. 2. Repeat a second time. This should resolve the error on the CT system. For questions, contact Gary Becker, Regulatory Affairs Manager at 800-421-1968 or email gmbecker@us.medical.canon or the Canon Service Representative at 800-521-1968
- Quantity
- 6 systems
- Distribution
- U.S.: CA, CO, FL, NY, and WY O.U.S.: None
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K181804"]
- 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