Class 2 Device Recall Fujifilm

• Date Initiated by Firm: February 03, 2006
• Date Posted: March 15, 2006
• Recall Status: Terminated on March 16, 2012
• Recall Number: Z-0622-06
• Recall Event ID: 34652
• 510(K)Number: K051553
• Product Classification: System, Image Processing, Radiological - Product Code LLZ
• Product: Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS
• Code Information: Versions 3.1.0 and 3.1.1
• FEI Number: 1000513161
• Recalling Firm/ Manufacturer: Fujifilm Medical System USA, Inc.; 419 West Ave; Stamford CT 06902-6300
• For Additional Information Contact: Richard R. Michelin; 800-431-1850
• Manufacturer Reason for Recall: Image orientation and orientation markers may not match when an image is rotated or flipped when the CT Image is preset.
• FDA Determined Cause: Other
• 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).
• Quantity in Commerce: 179 units
• Distribution: Nationwide Foreign: Canada, Japan, Germany
• 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