FDA-Device2016-04-13Class II
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.
Siemens Medical Solutions USA, Inc
Hazard
To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging.
Sold states
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.
Affected count
49 imaging systems
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1349-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief