FDA-Device2018-04-11Class II
Syngo.via. Medical Device Software. Picture archiving and communications system.
Siemens Medical Solutions USA, Inc
Hazard
A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated information could be sent to the referring physician when creating the formal report in the reporting system.
Sold states
Device is software only. No products are distributed to wholesale dealers, distributers or retailers
Affected count
236 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Syngo.via. Medical Device Software. Picture archiving and communications system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1303-2018Don't want to check this manually?
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