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Published: 2026-02-11Captured: 2026-02-20FUJIFILM Healthcare Americas CorporationProduct: FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
FDA issued a Class II enforcement action. Affects FUJIFILM Healthcare Americas Corporation. Reason: It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage gener.
- •Classification: Class II
- •Firm: FUJIFILM Healthcare Americas Corporation
- •Status: Ongoing
- •Distribution: US Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.
Reason
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 ...
Status:Ongoing
Distribution:US Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.
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