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).
Recall
- Recall Number
- Z-1348-2021
- Event Number
- 87579
- Firm
- Fujifilm Medical Systems U.S.A., Inc.
- FEI Number
- 1000513161
- Product Code
- LLZ
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- March 2, 2021
- Address
- 81 Hartwell Ave, Ste 300, Lexington, MA, 02421-3160
Description
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).
The wrong patient information may be displayed in the viewer or PowerJacket.
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.
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.
839 systems