Hitachi AIRIS Elite Magnetic Resonance Imaging Device
This recall has been terminated (originally issued June 14, 2005).
- Recall Initiated
- June 30, 2005
- Posted
- June 14, 2005
- Terminated
- September 14, 2010
- Recall Number
- Z-0890-05
- Quantity
- 35 devices
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.
Distribution
The product was distributed throughout the United States and to one consignee located in both Wales and London.
Lot / Code Info
H003 thru H059.
Root Cause
Other
Action Taken
The recalling firm is sending recall letters to all consignees.
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