Vital Images, Inc.: 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.

Recall number

Z-0186-2013

Recalling firm

Vital Images, Inc.

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.

Status

Terminated

Initiated

2012-08-13

Posted

2012-11-01

Terminated

2015-03-25

Reason

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.

Root cause

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

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

Lot, serial or model codes

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.

510(k) numbers

["K032748","K052632"]

PMA numbers

not on file

Product code

LLZ

Firm FEI

3001654007

Firm city

Plymouth

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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