X-ray systems recalled over welded contactor contacts that may overheat

Plain-English summary

The FDR Visionary Suite, model number CH-200, is being recalled by FUJIFILM Healthcare Americas Corporation, covering the software versions listed in the enforcement record.

The record states 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. The record states that as a result it cannot be denied that the circuit in question overheats and damages the surrounding parts, and that it may also cause smoke.

The record lists 16 units under model CH-200, with UDI-DI codes and serial numbers recorded in the enforcement record. Distribution was nationwide in the United States, in Alaska, California, Connecticut, Florida, Illinois, New Hampshire, Ohio and Wisconsin. The FDA has classified the action as Class II.

The enforcement record reports no injuries. Facilities should follow FUJIFILM's instructions.

The recalled product

Product

FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)

Manufacturer

FUJIFILM Healthcare Americas Corporation

Category

Medical Device — X-ray system

Hazard

• welded-contacts
• overheating
• smoke
• power-circuit

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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