Siemens Medical Solutions USA, Inc recalls Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communi…

Recall date

August 2, 2016

Source

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

Recall number

Z-2793-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Nationwide Distribution

Why it was recalled

Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown measurement value may be different from the real value.

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 picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.