Recall Z-1096-2017 ยท LNH System, Nuclear Magnetic Resonance Imaging
Hitachi Medical Systems America Inc
Hitachi Oasis MRI System - C-Spine Coil
| Date | Jan 6, 2017 |
| Status | Terminated |
| Reason | The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam. |
| Root cause | 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 | 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 acc |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072279 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE Hitachi Medical Systems America, Inc., Sep 21, 2007 |