medical Class II Updated 2021-01-27

Fujifilm Medical Systems U.S.A., Inc. recalls Synapse PACS Software Versions 5.1 and higher

Recalled Product

Synapse PACS Software Versions 5.1 and higher


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software Versions 5.1, 5.2, 5.3, 5.4, 5.5, and 5.7.
View official government recall

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