FUJIFILM Healthcare Recalls FDR Visionary Suite X-ray Systems Over Overheating and Smoke Risk

What Happened

FUJIFILM Healthcare Americas Corporation has initiated a voluntary recall of its FDR Visionary Suite X-ray systems. The recall was prompted by the discovery that electromagnetic contactors within the X-ray high-voltage generator cabinet could become welded. This defect allows electrical current to continue flowing to the power supply circuit even after the device has been turned off. This continuous current can lead to overheating of the circuit, damage to surrounding components, and the potential emission of smoke.

Which Products Are Affected

The recall affects 16 units of the FDR Visionary Suite, Model Number CH-200. The affected systems include the following versions and serial numbers:

• Version 566-16130-23 (UDI-DI: 04540217052226): Serial numbers MP95A9F6A001, MP95A9F6B001, MP95A9F74001, MP95A9F74002, MP95A9F76001, MP95A9F78001.
• Version 566-16130-31 (UDI-DI: 04540217057436): Serial number MP95AA783001.
• Version 566-16130-33 (UDI-DI: 04540217057450): Serial numbers MP95AA983001, MP95AA983002, MP95AA983003, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA988002.

The products were distributed to healthcare facilities in Alaska, California, Connecticut, Florida, Illinois, New Hampshire, Ohio, and Wisconsin.

What You Should Do

The firm initiated the recall process on January 9, 2026, by sending notification letters to affected customers. Facilities using the FDR Visionary Suite Model CH-200 should identify if their serial numbers match those listed in the recall. Affected users should follow the instructions provided in the notification letter from FUJIFILM Healthcare Americas Corporation regarding the inspection or repair of the high-voltage generator components.

Why This Matters

This defect presents a safety risk where medical equipment may overheat or produce smoke, potentially damaging the device and creating hazards for both patients and healthcare staff. The FDA has classified this as a Class II recall.

Source

Information provided by the FDA. Recall Number: Z-1299-2026.