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FDA-Device2026-02-11Class IIPROCESSING DEFECT

FUJIFILM FDR Visionary Suite X-ray system recalled for potential overheating and smoke hazard

Fujifilm
BURNELECTRICAL SHOCKFIRENationwide distribution

Stop using affected FUJIFILM FDR Visionary Suite units

FUJIFILM Healthcare Americas has recalled certain FDR Visionary Suite X-ray systems (Model CH-200) because internal electrical contacts can become welded together. This may allow power to continue flowing to the system even after it is turned off, which could cause the circuit to overheat, damage nearby parts, and create smoke.

  • Check if your device matches one of the affected serial numbers listed in the recall notice
  • Stop using the device immediately if it is one of the recalled units
  • Contact FUJIFILM Healthcare Americas or your equipment supplier for repair or replacement instructions
  • Do not attempt to operate or troubleshoot the device yourself
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.

Sold states
US Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.
Affected count
16 units
Manufactured in
81 Hartwell Ave Ste 300, N/A, Lexington, MA, United States
Products
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1299-2026

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