Recall Z-0152-2007 ยท MOS Coil, Magnetic Resonance, Specialty
Hitachi Medical Systems America Inc
Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150.
| Date | Nov 4, 2006 (initiated Aug 14, 2006) |
| Status | Terminated |
| Reason | Component defect/overheating device; A malfunctioning decoupling circuit in the CTL coil caused high current flow and circuit overheating. |
| Root cause | Other |
| Action | The recalling firm issued a Device Correction letter to the clinic customer on 9/15/2006 making them aware of this potential problem and of their completed corrective action on 8/14/2006, by a Service Rep visit. |
| Quantity | 1 unit |
| Distribution | The recalled unit was distributed to a single customer. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052172 | HHF1 MAGNETIC RESONANCE IMAGING SYSTEM Hitachi Medical Systems America, Inc., Sep 27, 2005 |