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Class 2 Device Recall Radiological Image Processing Software |
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Date Initiated by Firm |
February 23, 2010 |
Date Posted |
May 13, 2010 |
Recall Status1 |
Terminated 3 on June 07, 2012 |
Recall Number |
Z-1600-2010 |
Recall Event ID |
55222 |
510(K)Number |
K091498
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Product Classification |
system, image processing, radiological - Product Code LLZ
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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 MN 55447-5370
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For Additional Information Contact |
612-915-8000
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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.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = VITAL IMAGES, INC.
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