Canon Medical System, USA, INC.: 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 mult

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: 2 Lot/code info: UDI-DI: 04987670100208. Serial Number: BGE2292016, BGE2362017

UPC codes

04987670100208

Source

Official record: FDA (Device enforcement) ↗

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