INTERVENTIONAL ANGIOGRAPHY SYSTEM recallZ-2392-2023 · Canon Medical System, USA, INC. · initiated Jun 22, 2023
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
The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. There may be a delay in the procedure, but procedures can continue using the operators console, the switches on the back of the column, switches on the side of the flat panel detector, and the emergency stop will continue to function normally.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On 6/22/23 correction notices were emailed to customers who were advised of the following: If the table side control does not function then the procedure can continue using the operators console in the operator room, the switches on the back of the column and the switches on the side of the flat panel detector. The emergency stop should not be affected and will continue to function normally. Neither manual operation or auto positioning of the C-arm can be performed on the console during procedure, and the C-arm will not operate. A firm representative will contact you to schedule a time to replace the PWB on the console. Complete and return the customer reply form to [email protected] For questions, contact the InTouch team at [email protected] or your service representative at 800.521.1968
Recall details
- Recall number
- Z-2392-2023
- Status
- Open, Classified
- Initiated by the company
- Jun 22, 2023
- Posted by the FDA
- Aug 11, 2023
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 12
- Product code
- OWB
- FDA submissions
- K210900
- Distribution
- US Nationwide Distribution: NY, CO, IL, CA, MD, MN, WA
Product description
INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
Code information (models, lots, serial numbers)
UDI-DI: 04987670100192. INFX-8000C, Serial Numbers: BHA1992001, BHB2132003, SWC2242002, AFB1832003, SUC2262008, SUC2292010, BFB1972004, SUB2172002, SWC2262003
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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