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U.S. Department of Health and Human Services

Class 2 Device Recall Hitachi Oasis MRI System CSpine Coil

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  Class 2 Device Recall Hitachi Oasis MRI System CSpine Coil see related information
Date Initiated by Firm January 06, 2017
Create Date January 26, 2017
Recall Status1 Terminated 3 on November 08, 2018
Recall Number Z-1096-2017
Recall Event ID 76056
510(K)Number K072279  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product Hitachi Oasis MRI System - C-Spine Coil
Code Information M001 to M028, M029 to M083, M085 to M090, M092 to M104, M106, M110 to M111, M113 to M114, M116 to M123, M125, M128 to M131, M133, M139 to M141, M143 to M147, M150, M152, M154, M159, M161, M163, M166, M169 to M176, M179, M182, M183, M185, M186, M190, M194 to 196, M201, M207 to M238
Recalling Firm/
Manufacturer		 Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg OH 44087-2371
For Additional Information Contact Douglas J. Thistlethwaite
330-425-1313 Ext. 3720
Manufacturer Reason
for Recall		 The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.
FDA Determined
Cause 2		 Component design/selection
Action Hitachi sent an Urgent : Device Correction Notice dated January 3, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm plans to visit each site and replace the cable balun and also confirm receipt of the notification letter. The firm will quarantine returned baluns in their warehouse until they are reworked. For further questions regarding this recall please call (330) 425-1313 ext. 3720.
Quantity in Commerce 180 units
Distribution USA (nationwide) distribution. The product was distributed to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. There are three (3) government accounts for this recall: VA Medical Center/Lyster Army Health Clinic, Parma VA Medical Center, Outpatient Clinic. There are no Canada accounts for this recall. There are no Mexico accounts for this recall.
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 = LNH and Original Applicant = HITACHI MEDICAL SYSTEMS AMERICA, INC.
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