Canon Medical System, USA, INC.: Medical Device Recall in 2024 - (Recall #: Z-1155-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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 multi-tasking computer enable the system to fully meet the requirement for optimum image quality, safety, ease of use, advanced efficiency and improved workflow. The advanced floormounted system INFX-8000F uses a new flat panel detector to present fluoroscopic and fluorographic images of high quality.

Product Classification:

Class II

Date Initiated: November 15, 2023

Date Posted: February 28, 2024

Recall Number: Z-1155-2024

Event ID: 93844

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.

Status: Ongoing

Product Quantity: 2

Code Information:

UDI-DI: 04987670100208. Serial Number: BGE2292016, BGE2362017

Distribution Pattern:

US: CA, LA

Voluntary or Mandated:

Voluntary: Firm initiated