Recall Z-0890-05 ยท LNH System, Nuclear Magnetic Resonance Imaging
Hitachi Medical Systems America Inc
Hitachi AIRIS Elite Magnetic Resonance Imaging Device
| Date | Jun 14, 2005 (initiated Jun 30, 2005) |
| Status | Terminated |
| Reason | Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder. |
| Root cause | Other |
| Action | The recalling firm is sending recall letters to all consignees. |
| Quantity | 35 devices |
| Distribution | The product was distributed throughout the United States and to one consignee located in both Wales and London. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032232 | AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE Hitachi Medical Systems America, Inc., Sep 29, 2003 |