Recall Z-1199-03 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Medical Systems
Gyroscan ACS-NT system
| Date | Sep 12, 2003 (initiated May 2, 2002) |
| Status | Terminated |
| Reason | Patient burns related to high SAR levels and the combined use of Synergy Body Coil and synergy Flex-M coil |
| Root cause | Other |
| Action | The firm issued a Field Change Order to their field personnel instructing them to add new labeling to the User Manual. 05/02/2002 A letter was issued to customers. |
| Quantity | 112 total for all 3 devices |
| Distribution | The firm distributed units to hospitals and medical centers nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932645 | PHILIPS GYROSCAN TN 15 Philips Medical Systems, Inc., Dec 13, 1993 |