Recall Z-0910-06 ยท LNH System, Nuclear Magnetic Resonance Imaging
Hitachi Medical Systems America Inc
Magnetic Resonance Imaging Device
| Date | May 31, 2006 (initiated Feb 21, 2006) |
| Status | Terminated |
| Reason | The device has a software anomaly which causes the operating system to 'lock up' and data to become corrupted during service procedures. |
| Root cause | Other |
| Action | The recalling firm plans to notify their customers of this recall/soft ware correction during a scheduled visit to be conducted at each customer site by a Hitachi Field Service Technician. During the visit, the necessary corrective software will be installed. The visits/corrections began on: 2/21/06. |
| Quantity | 1129 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002420 | HITACHI ALTAIRE Hitachi Medical Systems America, Inc., Oct 17, 2000 |
| K022390 | HITACHI ALTAIRE Hitachi Medical Systems America, Inc., Oct 11, 2002 |
| K032232 | AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE Hitachi Medical Systems America, Inc., Sep 29, 2003 |
| K974212 | AIRIS II Hitachi Medical Systems America, Inc., Feb 9, 1998 |