INTERVENTIONAL ANGIOGRAPHY SYSTEM recallZ-1154-2024 · Canon Medical System, USA, INC. · initiated Nov 15, 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
VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoing exam, or the patient may need to be examined with another x-ray system.
FDA root cause category: Component change control
What the company is doing
On 11/15/23 correction notices were distributed to customers who were asked to do the following: 1) Should this issue occur please attempt to restart the system and contact your service representative. 2) A recalling firm representative will contact you to schedule a time to replace the flat panel detector on the console. The parts required to address the defect are expected to be available no earlier that December 2023. 3) Complete and return the customer reply form via email to [email protected] For questions, please contact our InTouch team at [email protected] or 800-421-1968, or 800.521.1968.
Recall details
- Recall number
- Z-1154-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 15, 2023
- Posted by the FDA
- Feb 16, 2024
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 1
- Product code
- OWB
- FDA submissions
- K210900
- Distribution
- US: CA, LA
Product description
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.
Code information (models, lots, serial numbers)
UDI-DI: 04987670100192, Serial Number: B1E22X2005
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
Other products in the same recall event
The FDA groups related products into one recall event (event 93844).
- Z-1155-2024 · Open, ClassifiedThe INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary graphic user interface and a multi-tasking com…
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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