Siemens Medical Solutions USA, Inc recalls software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, disp…

Recall date

January 29, 2016

Source

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

Recall number

Z-0826-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

US Nationwide Distribution including states of: AL AR AZ CA CO CT DE FL GA IL IN KS LA MA MD MI MN MO NC ND NE NJ NM NY OH OR PA SC TN TX UT VA WA and WI.

Why it was recalled

Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients.

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

What was recalled

software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images.