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Fujifilm Medical Systems U.S.A., Inc. recalls Synapse PACS Software Versions 5.1 and higher
Recalled January 27, 2021 · FDA recall Z-0878-2021 · Fujifilm Medical Systems U.S.A
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. · FDA Class II
Units
235
Sold at
Software was distributed to medical facilities nationwide throughout the U.S.
Description
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.
Product
Synapse PACS Software Versions 5.1 and higher
Manufacturer(s)
Fujifilm Medical Systems U.S.A., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →