Siemens Medical Solutions USA, Inc recalls Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, r…

Recall date

February 20, 2018

Source

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

Recall number

Z-1700-2018

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

USA (nationwide)

Why it was recalled

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

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 software 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.