Z-2366-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2015
- Initiation Date
- April 25, 2014
- Termination Date
- August 24, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 173 units
Product Description
Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The 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.
Reason for Recall
The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched.
Distribution Pattern
US Nationwide in the states: AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI & WY and the country of Mexico.
Code Information
Serial #'s: M001to M108, M110 to M175, M951 & M952.