| Class 2 Device Recall Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): | |
Date Initiated by Firm | August 13, 2012 |
Date Posted | November 01, 2012 |
Recall Status1 |
Terminated 3 on March 25, 2015 |
Recall Number | Z-0186-2013 |
Recall Event ID |
63104 |
510(K)Number | K032748 K052632 |
Product Classification |
System, image processing, radiological - Product Code LLZ
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Product | Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES):
VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2
VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2
VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea Enterprise Suite 1.3, 6.0, 6.1, and 6.2.
The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, DR, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography. The Vitrea VScore option is intended for cardiac scoring from whole body CT derived measurements, including non-invasive detection and quantification of atherosclerotic plaque. Two image processing options, EKG Gate and Auto Gate, allow the operator to select images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring. |
Code Information |
Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2 VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea Enterprise Suite 1.3, 6.0, 6.1, and 6.2. |
Recalling Firm/ Manufacturer |
Vital Images, Inc. 5850 Opus Parkway Suite 300 Plymouth MN 55343-4414
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For Additional Information Contact | 612-915-8000 |
Manufacturer Reason for Recall | Vital Images has found two potential errors in calcium score values in restored snapshots of studies generated through use of Vitrea or Vitrea Enterprise Suite. This issue affects Version 3.1 of Vitrea fX; Version 5.2 of Vitrea; Versions 6.0, 6.1 and 6.2 of Vitrea and Vitrea fX; and Versions 1.3, 6.0, 6.1 and 6.2 of Vitrea Enterprise Suite; and all updates to those versions. |
FDA Determined Cause 2 | Software design |
Action | Vital Images sent an "URGENT DEVICE CORRECTION" letter dated August 13, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter gave advise on how to resolve the two issues and advised consignees to immediately inform all potential users. Contact Customer Support at 1-800-208-3005 for questions regarding the notice. |
Quantity in Commerce | 2088 (1133 USA) |
Distribution | Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and the countries of ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BULGARIA, CANADA CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, FINLAND, FRANCE, GREAT BRITAIN, GEORGIA, GERMANY, GHANA, GREECE, GUAM, HONDURAS, HONG KONG, INDIA, INDONESIA, IRAQ, IRELAND, ITALY, IVORY COAST, JAPAN, JORDAN KAZAKHSTAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MALI, MOSCOW, MYANMAR, NAMIBIA, NETHERLANDS, NEW ZEALAND, NIGERIA, NORTHERN IRELAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA, SERBIA AND MONTENEGRO, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, THE NETHERLANDS, TIBET, TURKEY, UKRAINE, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM, AND YEMEN |
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
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