# FDA recall Z-1299-2026

> **FUJIFILM Healthcare Americas Corporation** · Class II · device recall initiated 2026-01-09.

## Product

FDR Visionary Suite;  Model Number: CH-200;  Version: (1) 566-16130-23, (2) 566-16130-31, (3)

## Reason for recall

It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.

## Distribution

US Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.

## Key facts

- **Recall number:** Z-1299-2026
- **Recalling firm:** FUJIFILM Healthcare Americas Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-09
- **Report date:** 2026-02-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lexington, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1299-2026

## Citation

> MORVS. FDA recall Z-1299-2026. Retrieved 2026-11-02 from https://api.morvs.ai/recall/Z-1299-2026. Source: US FDA. Licensed CC0.

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