Siemens Medical Solutions USA, Inc recalls SOMATOM go.Top, Model No. 11061648 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This comp…

Recall date

June 4, 2019

Source

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

Recall number

Z-1922-2019

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

US Nationwide distribution in the states of AL CA CT FL GA IL IN KS KY LA ME MI MO MS NC ND NE NH NY OH OK SD TN TX VA and WI

Why it was recalled

The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.

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

What was recalled

SOMATOM go.Top, Model No. 11061648 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies.