Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report,
FDA device recall Z-0862-2016 · posted 2016-02-23 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Siemens is releasing an updated software version to address several software issues including RGB images will show "?" since calculation of HU is not possible; save as option enabled; changes in access for loading studies; breast region is now properly fitted to segment boundary when clicking fit breast to screen.
- Action taken
- Siemens sent a Voluntary Correction and Removal Action letter dated December 30, 2015. The letter identified the product, the problem, and the action to be taken by the customer. Customers were notified that a software update VB10A_HF01/06 is being released simulataneously to eliminate the issue. Customers with questions were instructed to call 1-888-826-9702.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 68
- Distribution
- Nationwide Distribution including AL CA CT FL IN KS LA MA MD MI MN MO MS NE NY OH OR PA TX WA WI
- Date initiated
- 2015-12-22
- Date posted
- 2016-02-23
- Date terminated
- 2017-09-05
- Location
- Malvern, PA
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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 |