Recall Z-0358-06 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Medical Systems North America Co. Phillips
Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging.
| Date | Jan 6, 2006 (initiated Dec 9, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 96 |
| Distribution | 96 units distributed to 92 U.S. Customers |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940534 | GYROSCAN T10-NT (RELEASE 4 SERIES SOFTWARE) Philips Medical Systems, Inc., Nov 22, 1994 |