FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
USFDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Recalling Firm: FUJIFILM Healthcare Americas Corporation
Reason for Recall / Hazard
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.
Product Description & Identification
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Affected Products
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Additional Source Details
| Field | Value |
|---|---|
| City | Lexington |
| State | MA |
| Event id | 98124 |
| Address 1 | 81 Hartwell Ave Ste 300 |
| Address 2 | N/A |
| Code info | Model Number: CH-200; (1) Version: 566-16130-23; UDI-DI: 04540217052226; Serial numbers: MP95A9F6A001, MP95A9F6B001, MP95A9F74001, MP95A9F74002, MP95A9F76001, MP95A9F78001; (2) Version: 566-16130-31; UDI-DI: 04540217057436; Serial numbers: MP95AA783001; (3) Version: 566-16130-33; UDI-DI: 04540217057450; Serial numbers: MP95AA983001, MP95AA983002, MP95AA983003, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA988002; |
| Postal code | 02421-3160 |
| Report date | 20260211 |
| Product type | Devices |
| Product quantity | 16 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260109 |
| Initial firm notification | Letter |
| Center classification date | 20260205 |
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Overview
- Recalling FirmFUJIFILM Healthcare Americas Corporation
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.
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🚨 SAFETY ALERT: FUJIFILM Healthcare Americas Corporation - FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3) Check if your household is affected: https://therecallfile.com/recalls/fdr-visionary-suite-model-number-ch-200-version-1-566-16130-23-2-566-1/FDA-Z-1299-2026
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