FDANovember 26, 2019device

iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiography. The IMRIS iMRX system is the integration of a Siemens Artis zee family (biplane or floor or ceiling mounted single plane) and the IMRIS Neuro 3T System. T...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

There is a potential hardware error for the iMRX System with a generator A100. A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible

What to do

FDA enforcement status: Terminated

Brands named

deerfield imagingdeerfield

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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