Medical device recalls Moderate risk

Siemens Medical Solutions USA, Inc recalls Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicat…

Recall date
February 18, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1354-2015
FDA classification
Class II
Brand / firm
Siemens Medical Solutions USA, Inc
Sold / distributed
US Distribution: MA, WI, FL

Why it was recalled

Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived, will remain unarchived.

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. 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.

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