Recall Z-1227-03 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Medical Systems
Gyroscan ACS-NT with software versions R6x, R7x, R8x
| Date | Sep 12, 2003 (initiated Nov 21, 2002) |
| Status | Terminated |
| Reason | Patient burns from cables near or in contact with the patient during use |
| Root cause | Other |
| Action | On 11/21/02, the firm provided Field Change Order (FCO) 781 00006 to their field employees. This FCO instructed the field employees to visit the consignees and provide them with the addendums to the Instruction For Use Manual. |
| Quantity | 435 total devices |
| Distribution | The firm distributed units to hospitals and medical centers throughout the U.S. |
| 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 |