FDAMarch 2, 2021device

Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The wrong patient information may be displayed in the viewer or PowerJacket.

What to do

FDA enforcement status: Ongoing

Brands named

fujifilm medical systems ufujifilmfujifilm medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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