FDA-Device2018-01-31Class II
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.
Siemens Medical Solutions USA, Inc.
Hazard
Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.
Sold states
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.
Affected count
36 units.
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0405-2018Don'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