medical Class II Updated 2024-02-28

Canon Medical System, USA, INC. recalls The device is an X-ray system that is capable of radiographi

Recalled Product

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.


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: 04987670100192, Serial Number: B1E22X2005
View official government recall

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