Canon Medical System, USA, INC.: Medical Device Recall in 2024 - (Recall #: Z-1154-2024)

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 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.

Product Classification:

Class II

Date Initiated: November 15, 2023

Date Posted: February 28, 2024

Recall Number: Z-1154-2024

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: 1

Code Information:

UDI-DI: 04987670100192, Serial Number: B1E22X2005

Distribution Pattern:

US: CA, LA

Voluntary or Mandated:

Voluntary: Firm initiated