Reported Aug 19, 2015 · Terminated
Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system is an imaging device…
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?
- Oasis Coil Extension Cable used with
- Hitachi Oasis MRI System Product UsageThe Oasis 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 cross-sectional 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 Coil Extension Cable that is the subject of the removal action is an accessory that is used in conjunction with certain anatomy coils to aid in patient positioning
- Lot codes and dates
Serial #'s: M001to M108M110 to M175M951 & M952
- Amount recalled
- 173 units
Where it was sold
Why it was recalled
The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched.
This product could cause temporary or reversible health problems — stop using it.
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