medical Class II Updated 2024-02-28

Canon Medical System, USA, INC. recalls The INFX-8000F is designed to take advantage of the latest t

Recalled Product

The 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 computer enable the system to fully meet the requirement for optimum image quality, safety, ease of use, advanced efficiency and improved workflow. The advanced floormounted system INFX-8000F uses a new flat panel detector to present fluoroscopic and fluorographic images of high quality.


Hazard / Issue

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.

Issued by

FDA

Affected States: CA, LA
Lot/Code Info: UDI-DI: 04987670100208. Serial Number: BGE2292016, BGE2362017
View official government recall

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