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U.S. Department of Health and Human Services

Class 2 Device Recall Radiological Image Processing Software

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 Class 2 Recall
Radiological Image Processing Software
see related information
Date Posted May 13, 2010
Recall Status1 Terminated on June 07, 2012
Recall Number Z-1600-2010
Recall Event ID 55222
Premarket Notification
510(K) Number
K091498 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the licensing of CT lung or CT Colon.
Code Information Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2
Recalling Firm/
Manufacturer
Vital Images, Inc.
3300 Fernbrook Ln N Ste 200
Plymouth, Minnesota 55447-5370
Consumer Instructions No consumer action necessary
Manufacturer Reason
for Recall
Vital images, Inc is issuing a recall notice on their medical device software in the use of CT Lung and CT Colon in Vitrea 5.1, Vitrea fX 3.0 or Vitre Enterprise Suite 1.2. because incorrect measurements may result. Questions or comments are directed to the firm's Customer Support at support@vitalimages.com or at 1-800-208-3005.
FDA Determined
Cause 2
DESIGN: Software Design
Action Consignees were sent a Vital "Urgent Medical Device Software Recall Notice" letter dated 23 February 2010. The letter was addressed to "Dear Customer." The letter described the problem, product affected and provided recommendation to their customers. Questions or comments are directed to the firm's Customer Support at support@vitalimages.com or at 1-800-208-3005.
Quantity in Commerce 95
Distribution AZ, AR, CA, COT, CT, FL, GA, IN, IA, KY, LA, MD, MA, MI, MN, NV, NJ, NY, ND, OH, PA, SC, TX, VA, WA, WV, WI. AUSTRALIA, SPAIN, FRANCE, BELGIUM, NETHERLANDS, PERU, NIGERIA, SWEDEN, CANADA, SWITZERLAND, EGYPT, CHINA, GERMANY, PANAMA, TAIWAN, HONG KONG, VENEZUELA, SOUTH AFRICA, CHILE, MEXICO, KOREA, COLOMBIA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = VITAL IMAGES, INC.
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