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FDR Visionary Suite X-ray Generator
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MEDICAL DEVICE RECALLMODERATE

FDR Visionary Suite X-ray Generator

FUJIFILM is recalling FDR Visionary Suite X-ray generators due to a risk of overheating and smoke caused by faulty electromagnetic contactors.

What to do

Immediately stop using the device and contact FUJIFILM Healthcare Americas Corporation for inspection and repair.

Recalled
Listed
Updated
Recall No.
Z-1299-2026
Agency
FDA
Firm
FUJIFILM Healthcare Americas Corporation
Recall ID
98124
Status
ONGOING

Recall at a glance

Quantity recalled
16 units

Why it was recalled

FUJIFILM is recalling the FDR Visionary Suite X-ray high-voltage generator because electromagnetic contactors inside the cabinet may weld, causing the power supply circuit to remain energized after the device is turned off. This failure can lead to overheating, damage to surrounding components, and potential smoke. The affected units were distributed nationwide.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

CH-200

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification