Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS
FDA Recall Z-0622-06 · Posted 2006-03-15
Recalling FirmFujifilm Medical System USA, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2006-02-03
Date Terminated2012-03-16
Product Quantity179 units
Reason for Recall
Image orientation and orientation markers may not match when an image is rotated or flipped when the CT Image is preset.
Firm Action
FujiFilm Medical Systems USA notified users by letter dated 2/3/06. Users are requested to deactivate the CT Image Processing functionality SWAT (Synapse Web Administration Tool).
Root Cause
Other
Distribution Pattern
Nationwide Foreign: Canada, Japan, Germany
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.