Open, Classified

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).

FDA Recall Z-1348-2021 · Posted None

Recalling FirmFujifilm Medical Systems U.S.A., Inc.

Recall StatusOpen, Classified

Product CodeLLZ

Date Initiated2021-03-02

Product Quantity839 systems

Reason for Recall

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

Firm Action

On March 2, 2021, FUJIFILM Medical Systems U.S.A., Inc. (FUJIFILM) issued an Urgent Medical Device Recall notice for the voluntary recall of Synapse PACS versions 5.1 and higher via certified mail.

Root Cause

Software design

Distribution Pattern

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, Angola, Argentina, Austria, Australia, Belgium, Bermuda, Brazil, Canada, Switzerland, Chile, Colombia, Costa Rica, Czechia, Germany, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Indonesia, Israel, India, Italy, Jordan, Japan, Kuwait, Malta, Mexico, Malaysia, Netherlands, Peru, Philippines, Pakistan, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovenia, Slovakia, El Salvador, Thailand, Turkey, Uruguay, South Africa, Zimbabwe.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc. · 2016-02-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.