Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate
FDA device recall Z-1354-2015 · posted 2015-03-30 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived, will remain unarchived.
- Action taken
- Safety Advisory Notice, dated February 18, 2015, was sent to end users that identified the product, problem, and action to be taken. Users were advised not to manually remove the delete protection in the STS.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 4
- Distribution
- US Distribution: MA, WI, FL
- Date initiated
- 2015-02-18
- Date posted
- 2015-03-30
- 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 |
|---|---|---|
| SYNGO.PLAZA VB10A (K132532) | Siemens AG Healthcare | 2013-12-09 |
| SYNGO.PLAZA (K093612) | Siemens AG Medical Solutions | 2010-03-04 |
| SIENET TELERADIOLOGY PRODUCT LINE (K955394) | Siemens Medical Solutions USA, Inc. | 1996-02-21 |