FDA-Device2024-02-28Class II
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.
Canon Medical System, USA, INC.
Hazard
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.
Sold states
US: CA, LA
Affected count
1
Manufactured in
2441 Michelle Dr, N/A, Tustin, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1154-2024Don't want to check this manually?
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