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U.S. Department of Health and Human Services

Class 2 Device Recall Hitachi Oasis MRI Coil Extension Cable

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  Class 2 Device Recall Hitachi Oasis MRI Coil Extension Cable see related information
Date Initiated by Firm April 25, 2014
Date Posted August 10, 2015
Recall Status1 Terminated 3 on August 24, 2018
Recall Number Z-2366-2015
Recall Event ID 71431
510(K)Number K072279  
Product Classification Coil, magnetic resonance, specialty - Product Code MOS
Product 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.
Code Information Serial #'s: M001to M108, M110 to M175, M951 & M952.
Recalling Firm/
Manufacturer		 Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg OH 44087-2371
For Additional Information Contact Mr. Douglas J. Thistlethwaite
330-425-1313 Ext. 3720
Manufacturer Reason
for Recall		 The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Hitachi sent an Urgent: Device Removal Notice letter date April 24, 2014 to their customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers to discontinue using the Coil Extension Cable and that a Field Service Engineer will schedule a visit to remove the cable. For questions call 800-800-3106 ext 3720.
Quantity in Commerce 173 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MOS and Original Applicant = HITACHI MEDICAL SYSTEMS AMERICA, INC.
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