Recall Z-1348-2021 ยท LLZ System, Image Processing, Radiological
Fujifilm Medical Systems U.S.A., Inc.
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).
| Date | Mar 2, 2021 |
| Status | Open, Classified |
| Reason | The wrong patient information may be displayed in the viewer or PowerJacket. |
| Root cause | Software design |
| 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. |
| Quantity | 839 systems |
| Distribution | 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, Ang |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160108 | Synapse PACS Fujifilm Medical Systems U.S.A, Inc., Feb 3, 2016 |