Hitachi AIRIS Elite Magnetic Resonance Imaging Device
FDA device recall Z-0890-05 · posted 2005-06-14 · Terminated
Recall details
- Recalling firm
- Hitachi Medical Systems America Inc
- Reason for recall
- Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.
- Action taken
- The recalling firm is sending recall letters to all consignees.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 35 devices
- Distribution
- The product was distributed throughout the United States and to one consignee located in both Wales and London.
- Date initiated
- 2005-06-30
- Date posted
- 2005-06-14
- Date terminated
- 2010-09-14
- Location
- Twinsburg, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE (K032232) | Hitachi Medical Systems America, Inc. | 2003-09-29 |