Reported Jul 25, 2018 · Terminated
Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended to provide the physician…
Hitachi Medical Systems America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hitachi Medical Systems America Inc · 1959 Summit Commerce Park · Twinsburg, OH · 44087-2371
Is this the product you have?
- Hitachi Oasis MRI system Product UsageHitachi 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
- Lot codes and dates
M001 to M028M030 to M108M110 to M266M951M952
- Amount recalled
- 264
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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