FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Reported: February 11, 2026 Initiated: January 9, 2026 #Z-1299-2026
Product Description
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.
Details
- Recalling Firm
- FUJIFILM Healthcare Americas Corporation
- Units Affected
- 16 units
- Distribution
- US Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.
- Location
- Lexington, MA
Frequently Asked Questions
What product was recalled? ▼
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3). Recalled by FUJIFILM Healthcare Americas Corporation. Units affected: 16 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 11, 2026. Severity: Moderate. Recall number: Z-1299-2026.
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