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Fujifilm Medical Systems U.S.A., Inc. recalls Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and inf
Recalled October 19, 2016 · FDA recall Z-0073-2017 · Fujifilm Medical Systems U.S.A
Hazard
Image data for a patients image may not be correct · FDA Class II
Units
251 units
Sold at
US Nationwide Distribution.
Description
Image data for a patients image may not be correct
Product
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
Manufacturer(s)
Fujifilm Medical Systems U.S.A., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →