Siemens Medical Solutions USA, Inc recalls syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology information system (RIS) with inte…

Recall date

May 6, 2015

Source

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

Recall number

Z-1704-2015

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Nationwide Distribution

Why it was recalled

A potential exists for order transactions from interfaced HIS (Hospital Information System) systems to be lost during a restart of interface processes when using the Order Batching feature, leading to diagnosis delay.

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 Workflow SLR; The information system syngo Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration. The system electronically displays stores, retrieves, transfers, exchanges, and prints.