Class 2 Device Recall Vital, Vitrea fX and Vitrea Enterprise Suite fX

• Date Initiated by Firm: October 14, 2010
• Date Posted: December 21, 2010
• Recall Status: Terminated on May 15, 2012
• Recall Number: Z-0797-2011
• Recall Event ID: 57219
• 510(K)Number: K072821
• Product Classification: system, image processing, radiological - Product Code LLZ
• Product: Vital, Vitrea fX and Vitrea Enterprise Suite fX; ; Model number: Vitrea fX 2.1, fX 3.0, and fX 3.1; Vitrea Enterprise Suite (VES) fX 1.2 and VES fX 1.3; ; The Vitrea 4D CT Brain Perfusion option is intended for post processing based on dynamic CT images continuously acquired during the infection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion-related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.
• Code Information: none
• Recalling Firm/ Manufacturer: Vital Images, Inc.; 5850 Opus Parkway Suite 300; Plymouth MN 55343-4414
• For Additional Information Contact: 612-915-8000
• Manufacturer Reason for Recall: Vital Images Inc., reported that a software defect exists with Vitrea fX 2.1, 3.0 and 3.1 CT Brain Analysis whereby the annotated numeric ROI values on a batched perfusion map are incorrect when created using the auto batching function (from the right click menu) with the auto ROI templates enabled.
• FDA Determined Cause: Software design
• Action: Vital Images, Inc sent a Vital "Urgent Software Update Alert" letter dated 14 October 2010 to all Consignees/Customers. The letter described the product and problem. They advised, until new software is installed, that the customers can avoid obtaining incorrect values by tuning off ROI templates prior to selecting the batch option from the right click menu in the CT Brain Analysis application; and recommended that the customers re-examine any ROI perfusion values that were previously generated using automatic collage batching with ROI templates. Please direct any questions or comments to Customer Support at support@vitalimages.com or at 1-800-208-3005. Any help needed to install this software update can also be directed to Customer Support.
• Quantity in Commerce: 182
• Distribution: Worldwide distribution: USA including states of: AL, AZ, AR, CA, CO, FL, GA, IA, KY, LA, MD, MA, MI, MN, MO, MT, NY, NJ, ND, OH, PA, PR, TN, TX, WA, WI, and WY, and countries of: CANADA, NETHERLANDS, TAIWAN, CHINA, SINGAPORE, UNITED KINGDOM, BRAZIL, GERMANY, RUSSIA, THAILAND, FRANCE, REPUBLIC OF KOREA, SPAIN, PAKISTAN,IRELAND, JAPAN, AUSTRALIA, INDIA, CZECH REPUBLIC, HONG KONG, EGYPT, ITALY, AUSTRIA, SLOVAK IA, BULGARIA, LEBANON, ALGERA, TAIWAN, SOUTH ARICA, BELGIUM, MALAYSIA, DENMARK, and JORDAN.CANADA, NETHERLANDS, TAIWAN, CHINA, SINGAPORE, UNITED KINGDOM, BRAZIL, GERMANY, RUSSIA, THAILAND, FRANCE, REPUBLIC OF KOREA, SPAIN, PAKISTAN,IRELAND, JAPAN, AUSTRALIA, INDIA, CZECH REPUBLIC, HONG KONG, EGYPT, ITALY, AUSTRIA, SLOVAK IA, BULGARIA, LEBANON, ALGERA, TAIWAN, SOUTH ARICA, BELGIUM, MALAYSIA, DENMARK, JORDAN.
• 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 = VITAL IMAGES, INC.