Siemens Medical Solutions USA, Inc recalls SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This compu…

Recall date

May 28, 2019

Source

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

Recall number

Z-1917-2019

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

US Nationwide distributed in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, PA, SC, TX, VA, WA, WI, and Puerto Rico.

Why it was recalled

The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.

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.All (Model #11061630), 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.