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.
Recall
- Recall Number
- Z-2479-2018
- Event Number
- 80464
- Firm
- Hitachi Medical Systems America Inc
- FEI Number
- 1528028
- Product Code
- LNH
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- June 18, 2018
- Terminated
- April 20, 2020
- Address
- 1959 Summit Commerce Park, Twinsburg, OH, 44087-2371
Description
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.
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.
On June 18, 2018, the firm distributed an Urgent Medical Device Correction Notices to affected customers. Customers were informed of the issue and advised that the firm would be adding protective guards to both sides of the belt to prevent accidental contact. The firm expects to begin installing the guards around fall 2018. In the meantime, customers are advised to avoid direct contact with the stainless steel belt. Questions, comments, or requests may be sent to [email protected].
Worldwide Distribution - US Nationwide distribution.in the states of Mexico.
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