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). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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).
Brand
Fujifilm Medical Systems U.S.A., Inc.
Lot Codes / Batch Numbers
Software version: 5.1 to 5.7.200
Products Sold
Software version: 5.1 to 5.7.200
Fujifilm Medical Systems U.S.A., Inc. is recalling Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web base due to The wrong patient information may be displayed in the viewer or PowerJacket.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The wrong patient information may be displayed in the viewer or PowerJacket.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026