FDA-Device2021-01-27Class II
Synapse PACS Software Versions 5.1 and higher
Fujifilm Medical Systems U.S.A., Inc.
Hazard
There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.
Sold states
Software was distributed to medical facilities nationwide throughout the U.S.
Affected count
235
Manufactured in
81 Hartwell Ave Ste 300, N/A, Lexington, MA, United States
Products
Synapse PACS Software Versions 5.1 and higher
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0878-2021Don't want to check this manually?
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