PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: March 2, 2016 Initiated: December 22, 2015 #Z-0862-2016

Product Description

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.

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.

Details

Units 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
Location
Malvern, PA

Frequently Asked Questions

What product 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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 68.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 2, 2016. Severity: Moderate. Recall number: Z-0862-2016.

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