Hitachi Oasis MRI System - C-Spine Coil
FDA Recall Z-1096-2017 · Posted None
Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2017-01-06
Date Terminated2018-11-08
Product Quantity180 units
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.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.