Siemens Medical Solutions USA, Inc recalls Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.

Recall date

November 18, 2015

Source

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

Recall number

Z-0597-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Nationwide Distribution including: AL, AZ, CA, CO, FL, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NC, NY, OH, OK, PA, SC, TN, TX, VA, and WI.

Why it was recalled

Potential post-processing software issue when using tabcard "4D" on X-Workplace with software version VD10E. A too small measurement in the MPRs of a volume when images are acquired with a CT scanner with a tilted gantry. In a 2x2 layout, the 4D tabcard will show an incorrect, too small length measurement. This could result in selecting a device of the wrong size, which then needs to be exchanged.

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

What was recalled

Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.