Siemens Medical Solutions USA, Inc recalls Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, mani…

Recall date

August 5, 2016

Source

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

Recall number

Z-2852-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Distributed Nationwide

Why it was recalled

Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high.

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.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.