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FDA (Device enforcement)Recalled 2025-12-19class ii

Canon Medical System, USA, INC.: Alphenix INFX-8000H, interventional fluoroscopic x-ray system

Hazard

It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed

Details from the source

Reason for recall: It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed Distribution: Worldwide distribution - US Nationwide and the country of Dominican Republic. Quantity: 3 units Lot/code info: serial numbers: D2A1672385, A2A20Z2165, B2A1692426.

Source

Official record: FDA (Device enforcement)

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

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