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U.S. Department of Health and Human Services

Class 2 Device Recall Fujifilm

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  Class 2 Device Recall Fujifilm see related information
Date Initiated by Firm February 03, 2006
Date Posted March 15, 2006
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = FUJIFILM MEDICAL SYSTEMS USA, INC.
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