Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology information systems.
This recall has been terminated (originally issued February 23, 2016).
- Recall Initiated
- December 22, 2015
- Posted
- February 23, 2016
- Terminated
- September 5, 2017
- Recall Number
- Z-0862-2016
- Quantity
- 68
- Firm Location
- Malvern, PA
- Official Source
- View on FDA website ↗
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.
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
Lot / Code Info
Device model numbers: 10863171, 10863172, 10863173
Root Cause
Software design
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.