# FDA recall Z-1155-2024

> **Canon Medical System, USA, INC.** · Class II · device recall initiated 2023-11-15.

## Product

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.

## 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

## Key facts

- **Recall number:** Z-1155-2024
- **Recalling firm:** Canon Medical System, USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-15
- **Report date:** 2024-02-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tustin, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1155-2024

## Citation

> AI Analytics. FDA recall Z-1155-2024. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-1155-2024. Source: US FDA. Licensed CC0.

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