Recall Z-2314-2012 ยท MOS Coil, Magnetic Resonance, Specialty
Quality Electrodynamics LLC
TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician.
| Date | Sep 6, 2012 (initiated Jul 27, 2012) |
| Status | Terminated |
| Reason | On July 27, 2012, it was reported to the firm that the Siemens 3T 15ch Knee Coil was not functional because the coil identification code for the device was incorrect. |
| Root cause | Error in labeling |
| Action | Since all of the devices were located at various Siemens distribution locations, all communications were internal to Siemens concerning bringing the coils from one warehouse to another. |
| Quantity | 17 units |
| Distribution | Worldwide distribution: USA (nationwide): Tennessee only and country of: Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082636 | TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T Quality Electrodynamics, Sep 25, 2008 |