Recall Z-1200-03 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Medical Systems
Gyroscan NT-Intera 1.5T
| 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 | see above |
| Distribution | The firm distributed units to hospitals and medical centers nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.