Magnetic Resonance Imaging Device
FDA device recall Z-0910-06 · posted 2006-05-31 · Terminated
Recall details
- Recalling firm
- Hitachi Medical Systems America Inc
- Reason for recall
- The device has a software anomaly which causes the operating system to 'lock up' and data to become corrupted during service procedures.
- Action taken
- The recalling firm plans to notify their customers of this recall/soft ware correction during a scheduled visit to be conducted at each customer site by a Hitachi Field Service Technician. During the visit, the necessary corrective software will be installed. The visits/corrections began on: 2/21/06.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 1129
- Distribution
- Nationwide
- Date initiated
- 2006-02-21
- Date posted
- 2006-05-31
- Date terminated
- 2012-02-16
- Location
- Twinsburg, OH
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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 |
| HITACHI ALTAIRE (K022390) | Hitachi Medical Systems America, Inc. | 2002-10-11 |
| HITACHI ALTAIRE (K002420) | Hitachi Medical Systems America, Inc. | 2000-10-17 |
| AIRIS II (K974212) | Hitachi Medical Systems America, Inc. | 1998-02-09 |