Hitachi AIRIS II MRI System
This recall has been terminated (originally issued June 14, 2006).
- Recall Initiated
- April 25, 2006
- Posted
- June 14, 2006
- Terminated
- October 29, 2008
- Recall Number
- Z-1115-06
- Quantity
- 248
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
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.
Distribution
The devices were distributed to consignees located throughout the United States.
Lot / Code Info
Serial Numbers: C322- to C546; and C746 to C772
Root Cause
Other
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.