Canon Medical System, USA, INC.: 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 i

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.

Details from the source

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. Distribution: US: CA, LA Quantity: 1 Lot/code info: UDI-DI: 04987670100192, Serial Number: B1E22X2005

UPC codes

04987670100192

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.