MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnosti
FDA device recall Z-1308-2015 · posted 2015-03-20 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outputs could exceed IEC60601-2-33 limits and peripheral nerve stimulation could occur.
- Action taken
- A Customer Safety Advisory Notice, dated March 6, 2015, was sent to end users to inform them of the potential issue and what measures were being taken to mitigate possible risks.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 132
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-03-09
- Date posted
- 2015-03-20
- Date terminated
- 2016-08-17
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO (K121434) | Siemens Medi Cal Solutions, Inc. | 2012-11-05 |