Magnetom Espree. Magnetic Resonance Imaging System. model number 10018165
FDA device recall Z-1529-05 · posted 2005-09-09 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- there is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore
- Action taken
- The recalling firm issued via certified mail a Customer Safety Advisory to the affected customers per Update Instructions MR031/05/S. the letter informs customers of the potential issue and provides instructions to avoid its occurrence.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNN
- Quantity affected
- 209 units
- Distribution
- The products were shipped to medical facilities and MRI facilities nationwide.
- Date initiated
- 2005-08-12
- Date posted
- 2005-09-09
- Date terminated
- 2006-07-19
- Location
- Malvern, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAGNETOM ESPREE SYSTEM (K041112) | Siemens Medical Solutions USA, Inc. | 2004-07-21 |