Siemens Medical Solutions USA, Inc. recalls Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display…

Recall date

July 25, 2017

Source

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

Recall number

Z-0405-2018

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc.

Sold / distributed

USA (nationwide) Distribution to the states of: MA, CA, NC, WI, NY, NE, PA, AL, NJ, MO, MI, TX, MS, KS, LA, CT, MD, LA, CO, OK, MN and TN.

Why it was recalled

Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.

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 Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. It supports the physician in diagnosis and treatment planning.