INTERVENTIONAL ANGIOGRAPHY SYSTEM recallZ-1289-2022 · Canon Medical System, USA, INC. · initiated May 3, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Canon Medical System, USA, INC. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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 [email protected] or the Canon Service Representative at 800-521-1968
Recall details
- Recall number
- Z-1289-2022
- Status
- Open, Classified
- Initiated by the company
- May 3, 2022
- Posted by the FDA
- Jun 24, 2022
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 6 systems
- Product code
- OWB
- FDA submissions
- K181804
- Distribution
- U.S.: CA, CO, FL, NY, and WY O.U.S.: None
Product description
System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- INTERVENTIONAL ANGIOGRAPHY SYSTEM INFX-8000CCanon Inc. · System, x-ray, fluoroscopic, image-intensified4 recalls3 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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