Recall Z-2564-2014 ยท LNH System, Nuclear Magnetic Resonance Imaging
Hitachi Medical Systems America Inc
Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation.
| Date | Sep 2, 2014 (initiated Aug 18, 2014) |
| Status | Terminated |
| Reason | The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard. |
| Root cause | Device Design |
| Action | Letters will be sent to customers. Hatachi Serivce will be sent to each site to exchange the Gradient Coil Assembly. |
| Quantity | 39 systems |
| Distribution | Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, ID, KS, KY, MD, MS, NY, OH, and WY; countries of: Japan, Brazil, France, Germany, and Kyrgyzstan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113145 | ECHELON OVAL MRI SYSTEM Hitachi Medical Systems America, Inc., May 1, 2012 |