Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging.
FDA device recall Z-0358-06 · posted 2006-01-06 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- The Gyroscan NT MRI system has a computer software problem which results in images from one patient being placed into another patient's image record.
- Action taken
- Product safety notification sent certified mail to each customer explaining the problem. A mandatory software upgrade to correct the problem will be installed starting the first quarter of 2006 and be completed by the third quarter of 2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 96
- Distribution
- 96 units distributed to 92 U.S. Customers
- Date initiated
- 2005-12-09
- Date posted
- 2006-01-06
- Date terminated
- 2008-05-20
- Location
- Bothell, WA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GYROSCAN T10-NT (RELEASE 4 SERIES SOFTWARE) (K940534) | Philips Medical Systems, Inc. | 1994-11-22 |