RecallDepth

Synapse Version 2.2.1 and 2.3.1 software

Company
Fujifilm Medical System Usa, Inc.
Recall Initiated
May 12, 2003
Posted
June 12, 2003
Terminated
May 25, 2004
Recall Number
Z-0932-03
Quantity
54 units
Firm Location
Stamford, CT

Reason for Recall

Synapse Version 2.2.1 and 2.3.1 Software [Free-Hand Region] may lead to incorrect density calculations during CT scan

Distribution

Nationwide Foreign: Canada, Germany, Israel, Japan

Lot / Code Info

Verson 2.2.1 and 2.3.1.

Root Cause

Other

Action Taken

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.

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