Siemens Medical Solutions USA, Inc recalls Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report,…

Recall date

December 22, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0862-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.