Hitachi Medical Systems America Inc recalls Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended to provide the physician…

Recall date

June 18, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2479-2018

FDA classification

Class II

Brand / firm

Hitachi Medical Systems America Inc

Sold / distributed

Worldwide Distribution - US Nationwide distribution.in the states of Mexico.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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, and curved crosssectional images that display the internal structure of the head, body, or extremities. The images produced by the MR systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.