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 / numberBarcodesProduct 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:27 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.