Magnetic Resonance Imaging. Brand names: Concerto, Concerto Upgrade, Syngo Harmony, Syngo Harmony 087S, Syngo Harmony Up
FDA device recall Z-0175-03 · posted 2003-12-03 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Equipment SAR monitor does not accept new patient data, incorrect RF levels may be administered to the patient.
- Action taken
- The recalling firm field representatives are visiting each location to correct the problem through a software upgrade.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 118 units
- Distribution
- The products were shipped nationwide to hospitals and medical imagining centers.
- Date initiated
- 2003-10-16
- Date posted
- 2003-12-03
- Date terminated
- 2004-08-25
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO MR 2002B (K020991) | Siemens Medical Solutions USA, Inc. | 2002-06-13 |