FUJIFILM Healthcare Americas Corporation: FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- FUJIFILM Healthcare Americas Corporation
- Product
- FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.
- Recall initiated
- 2026-01-09
- 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;
- Product quantity
- 16 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Lexington
- State
- MA
- Country
- United States
- Event id
- 98124
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