Fujifilm Medical Systems U.S.A., Inc.: FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate digital

Is my product affected?

FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in al

• UPC 04540217052226

Check against the official notice below — it lists the full affected range.

What happened

Fujifilm Medical Systems is recalling three units of the FUJIFILM FDR Visionary Suite with CH-200 model X-ray ceiling units due to a potential issue where cracks may develop over time on the tube holding shaft near the base of the tube mounting flange. The X-ray tube assembly is mounted to this flange, and the structural integrity of the shaft could be compromised as cracks form. The affected units were distributed in the United States and can be identified by their specific serial numbers: MP95A9F6B001, MP95A9F6A001, and MP95A8F5A001.

The recall record does not specify a remedy or required action for consumers to take regarding these devices.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography System FDR Visionary Suite. The X-ray tube assembly in these devices is mounted to a tube mounting flange, which is part of the tube holding shaft. where cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.

Details from the source

Reason for recall: A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography System FDR Visionary Suite. The X-ray tube assembly in these devices is mounted to a tube mounting flange, which is part of the tube holding shaft. where cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. Distribution: US Distribution. Quantity: 3 Lot/code info: UDI: (01)04540217052226(21)MP95A9F6B001; (01)04540217052226(21)MP95A9F6A001; (01)04540217052226(21)MP95A8F5A001. Serial Numbers: FDR Visionary Suite System S/N MP95A9F6B001 MP95A9F6A001 MP95A8F5A001

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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