MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produce
FDA device recall Z-1663-2014 · posted 2014-05-27 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals.
- Action taken
- A customer safety advisory notice, dated April 24, 2014 was sent to notify direct accounts of the delivery of user manuals.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 5
- Distribution
- Distributed in the states of MN, CA, CO, TX, and IA.
- Date initiated
- 2014-04-24
- Date posted
- 2014-05-27
- Date terminated
- 2015-01-08
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAGNETOM AERA AND MAGNETOM SKYRA (K111242) | Siemens Medical Solutions USA, Inc. | 2011-11-23 |