Home / Recalls / Medical Devices
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 physic
Recalled July 25, 2018 · FDA recall Z-2479-2018 · Hitachi Medical Systems America
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. · FDA Class II
Units
264
Sold at
Worldwide Distribution - US Nationwide distribution.in the states of Mexico.
Description
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.
Product
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.
Manufacturer(s)
Hitachi Medical Systems America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →