Siemens Medical Solutions USA, Inc recalls A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute…

Recall date

January 18, 2016

Source

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

Recall number

Z-1349-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

US (nationwide) including the states of AL, CA, CO, CT, FL, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OK, OR, PA, TN, TX, and WI.

Why it was recalled

To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging.

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

What was recalled

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.