INTERVENTIONAL ANGIOGRAPHY SYSTEM recallZ-0108-2027 · Canon Medical System, USA, INC. · initiated Aug 26, 2026
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
Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error
FDA root cause category: Process control
What the company is doing
On August 26, 2026, Canon Medical Systems USA, Inc. issued a Urgent: Medical Device Correction notification to affected consignees via mail. Canon ask consignees to take the following actions: 1. Should this problem occur before inspection of the tightening of the bolt(s) is implemented on your system, please stop using the device and call your service representative. 2. Additionally, it is strongly requested that you share the contents of this letter with all users as well as clinical engineering or biomedical group at your facility. 3. A representative of Canon Medical Systems USA will contact you to schedule a time to inspect the tightening and properly fixing of the bolt(s) to correct this issue with your system(s). 4. If you have any questions regarding this matter, please contact your service representative contact our InTouch team at (800) 521-1968 or by email at [email protected]. 5. Canon respectfully requests that the attached form be completed and returned via email to [email protected].
Recall details
- Recall number
- Z-0108-2027
- Status
- Open, Classified
- Initiated by the company
- Aug 26, 2026
- Posted by the FDA
- Oct 7, 2026
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 1 unit
- Product code
- OWB
- FDA submissions
- K210900
- Distribution
- US Nationwide distribution in the state of ID.
Product description
Alphenix INFX-8000C/B5
Code information (models, lots, serial numbers)
Serial no. B5F2532011/UDI: 4987670100192
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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