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.

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

Code information: Model # 10014063

Distribution pattern: 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.