FDA-Device2020-07-08Class II
Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
Fujifilm Medical Systems U.S.A., Inc.
Hazard
Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice location of the image and/or the slice direction could be incorrect as well, and result in misdiagnosis
Sold states
Nationwide
Affected count
135 units
Manufactured in
81 Hartwell Ave Ste 300, N/A, Lexington, MA, United States
Products
Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2471-2020Don't want to check this manually?
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