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Recall Observatory FDA recall evidence

Device product

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.

Z-0862-2016

December 22, 2015

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 73041
Status
Terminated
Classification
Class II
Quantity
68
Official record key
device-enforcement:Z-0862-2016

Official wording

Reason: 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.

Code information: Device model numbers: 10863171, 10863172, 10863173

Distribution pattern: Nationwide Distribution including AL CA CT FL IN KS LA MA MD MI MN MO MS NE NY OH OR PA TX WA WI

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software version to address several software issues including RGB images will