Recall Z-1115-06 ยท LNH System, Nuclear Magnetic Resonance Imaging
Hitachi Medical Systems America Inc
Hitachi AIRIS II MRI System
| Date | Jun 14, 2006 (initiated Apr 25, 2006) |
| Status | Terminated |
| Reason | Improper Assembly-The AIRIS/AIRIS II MRI system has the potential for the input wiring of a power transformer to overheat due to damaged wiring or possible loose connections. |
| Root cause | Other |
| Action | The recalling firm plans to inspect the transformer connections for damaged wiring and check the connections for tightness and tighten as necessary. The inspections and possible corrections began on 4/25/2006 and are in the process of being conducted by the firm''s Field Service Engineers. The firm anticipates trhat these actions will be completed by 6/25/2006. |
| Quantity | 248 |
| Distribution | The devices were distributed to consignees located throughout the United States. |
| FDA record | Open on fda.gov |