Siemens Medical Solutions USA, Inc recalls Syngo.via. Medical Device Software. Picture archiving and communications system.

Recall date

January 8, 2018

Source

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

Recall number

Z-1303-2018

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Device is software only. No products are distributed to wholesale dealers, distributers or retailers

Why it was recalled

A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated information could be sent to the referring physician when creating the formal report in the reporting system.

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.via. Medical Device Software. Picture archiving and communications system.