FDA-Device2016-09-28Class II
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
Siemens Medical Solutions USA, Inc
Hazard
Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high.
Sold states
Distributed Nationwide
Affected count
338 systems
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2852-2016Don't want to check this manually?
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