Recall Z-0175-03 ยท LNH System, Nuclear Magnetic Resonance Imaging
Siemens Medical Solutions USA, Inc
Magnetic Resonance Imaging. Brand names: Concerto, Concerto Upgrade, Syngo Harmony, Syngo Harmony 087S, Syngo Harmony Upgrade, Syngo Sonata, Syngo Sonata Upgrade, Syngo Symphony, Syngo Symphony Q, and Syngo Symphony Upgrade.
| Date | Dec 3, 2003 (initiated Oct 16, 2003) |
| Status | Terminated |
| Reason | Equipment SAR monitor does not accept new patient data, incorrect RF levels may be administered to the patient. |
| Root cause | Other |
| Action | The recalling firm field representatives are visiting each location to correct the problem through a software upgrade. |
| Quantity | 118 units |
| Distribution | The products were shipped nationwide to hospitals and medical imagining centers. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020991 | SYNGO MR 2002B Siemens Medical Solutions USA, Inc., Jun 13, 2002 |