Fujifilm Medical Systems U.S.A., Inc. recalls Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on a…

Recall date

March 2, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1348-2021

FDA classification

Class II

Brand / firm

Fujifilm Medical Systems U.S.A., Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY and the countries of United Arab Emirates, An…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).