Fujifilm Medical System USA, Inc. Synapse Version 2.2.1 and 2.3.1 software Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Synapse Version 2.2.1 and 2.3.1 software
Brand
Fujifilm Medical System USA, Inc.
Lot Codes / Batch Numbers
Verson 2.2.1 and 2.3.1.
Products Sold
Verson 2.2.1 and 2.3.1.
Fujifilm Medical System USA, Inc. is recalling Synapse Version 2.2.1 and 2.3.1 software due to Synapse Version 2.2.1 and 2.3.1 Software [Free-Hand Region] may lead to incorrect density calculations during CT scan. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Synapse Version 2.2.1 and 2.3.1 Software [Free-Hand Region] may lead to incorrect density calculations during CT scan
Recommended Action
Per FDA guidance
FujiFilm notified users via letter notification during the week of May 12, 2003. Users wll be visited by a Regional Service Engineer to install the corrected software.
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