Hitachi AIRIS II MRI System
FDA device recall Z-1115-06 · posted 2006-06-14 · Terminated
Recall details
- Recalling firm
- Hitachi Medical Systems America Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 248
- Distribution
- The devices were distributed to consignees located throughout the United States.
- Date initiated
- 2006-04-25
- Date posted
- 2006-06-14
- Date terminated
- 2008-10-29
- Location
- Twinsburg, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HITACHI AIRIS II (K001334) | Hitachi Medical Systems America, Inc. | 2000-07-06 |
| AIRIS II (K974212) | Hitachi Medical Systems America, Inc. | 1998-02-09 |