Syngo.plaza VB10A, Picture Archiving and Communication System
FDA device recall Z-2892-2016 · posted 2016-09-27 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Software upgrade to eliminate several issues
- Action taken
- Siemens notified customers via mail on 09/07/2016 informing them of the latest syngo.plaza software change that was available to address several issues.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 47 systems
- Distribution
- Distributed Nationwide
- Date initiated
- 2016-09-06
- Date posted
- 2016-09-27
- Date terminated
- 2017-05-08
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO.PLAZA VB10A (K132532) | Siemens AG Healthcare | 2013-12-09 |