FDAJune 18, 2018device

Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The Oasis system produces transverse, coronal, sagittal, oblique,...

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

The hazard

The stainless steel belt which runs the length of the table underneath the tabletop is exposed when the tabletop is extended into the magnet for scanning. The firm has received two complaints where technologists have cut their fingers on this belt.

What to do

FDA enforcement status: Terminated

Brands named

hitachi medical systems americahitachihitachi medical

Recall history

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

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