medical Class II Updated 2018-05-16

Siemens Medical Solutions USA, Inc recalls Syngo.plaza software VB10A model numbers: 10863171, 10863172

Recalled Product

Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.


Hazard / Issue

Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Serial Numbers
View official government recall

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