Class 2 Device Recall Fujufilm

• Date Initiated by Firm: May 12, 2003
• Date Posted: June 12, 2003
• Recall Status: Terminated on May 25, 2004
• Recall Number: Z-0932-03
• Recall Event ID: 26390
• 510(K)Number: K991257
• Product Classification: System, Image Processing, Radiological - Product Code LLZ
• Product: Synapse Version 2.2.1 and 2.3.1 software
• Code Information: Verson 2.2.1 and 2.3.1.
• FEI Number: 1000513161
• Recalling Firm/ Manufacturer: Fujifilm Medical System USA, Inc.; 419 West Avenue; Stamford CT 06902
• For Additional Information Contact: Frank Gianelli; 203-602-3774
• Manufacturer 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
• FDA Determined Cause: Other
• Action: 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.
• Quantity in Commerce: 54 units
• Distribution: Nationwide Foreign: Canada, Germany, Israel, Japan
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LLZ