Reported Feb 11, 2026 · Ongoing
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
FUJIFILM Healthcare Americas Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: FUJIFILM Healthcare Americas Corporation · 81 Hartwell Ave Ste 300 · Lexington, MA · 02421-3160
Is this the product you have?
- FDR Visionary Suite
- Model NumberCH-200
- Version
(1) 566-16130-23(2) 566-16130-31(3)
- Lot codes and dates
10 of 10 products
Products covered by this recall Model / number Barcodes Product as published CH-200— — (1) Version: 566-16130-23 — 04540217052226UDI-DI: 04540217052226 — Serial numbers: MP95A9F6A001, MP95A9F6B001, MP95A9F74001, MP95A9F74002, MP95A9F76001, MP95A9F78001 — (2) Version: 566-16130-31 — 04540217057436UDI-DI: 04540217057436 — Serial numbers: MP95AA783001 — (3) Version: 566-16130-33 — 04540217057450UDI-DI: 04540217057450 — Serial numbers: MP95AA983001, MP95AA983002, MP95AA983003, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA988002 - Amount recalled
- 16 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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