Medical Device Recall: 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, be
Canon Medical System, USA, INC. · November 15, 2023
Reason for Recall
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.
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.
Distribution
US: CA, LA
States Affected
CA, LA
Quantity Affected
1
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1154-2024
Status: ongoing
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