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Siemens Medical Solutions USA, Inc recalls A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute,
Recalled April 13, 2016 · FDA recall Z-1349-2016 · Siemens Medical Solutions USA
Hazard
To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging. · FDA Class II
Units
49 imaging systems
Sold at
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.
Description
To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging.
Product
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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →