Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multidimensional digital imag
Check against the official notice below — it lists the full affected range.
Vital Images, Inc. is recalling certain versions of its Vitrea diagnostic software due to a potential measurement error that occurs when images are rotated during reconstruction by the scanner at non-90 degree increments. The affected software includes Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect), and Vitrea fX prior to version 6.3.3, with certain exceptions (versions 6.1.6, 6.2.3, and 6.3 are not affected). Approximately 7,654 units have been distributed worldwide, including throughout the continental United States and numerous countries internationally.
The source document does not specify a remedy for consumers to address this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Vital Images has found a potential error in measurement generated through the software which affects all versions of Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3. This error occurs when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/axia
Reason for recall: Vital Images has found a potential error in measurement generated through the software which affects all versions of Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3. This error occurs when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/axia Distribution: Worldwide Distribution - All states in continental USA including DC, PR and the countries of ALGERIA, ARGENTINA, ANGOLA, ARMENIA, AUSTRALIA, AUSTRIA, BENGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL BULAGARIA, CAMBODIA, CANADA, CENTRAL AFRICAN REPUBLIC, CHAD, CHILE, CHINA , COLOMBIA, CONGO, CROATIA, CYRPRUS, CZECH REPUBLIC, DENMARK, DJIBOUTI, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, ETH Quantity: 7649 (Expnaded 5/28/13 to 7654) Lot/code info: Serial Number 5080109343 5080109769 5080109726 5080123222 5080108401 5080107812 5080107804 5080107790 5080108428 5070933221 5070933248 5070933264 5070933272 5070933256 5080123109 5050411467 5080103442 5080103418 5090110913 5070934023 5080103434 5070931695 5080110775 5080113081 5080102977 5080103272 5080113340 5080121009 5080121122 5080121092 5080121106 5080121114 5080120827 5080111631 5080111755 5080116595 5080116609 5080116617 5080112883 5080122439 5080117214 5080119764 5080119772 5080119780 5080123095 5080121769 5080121750 5090102805 5070222244 5060213870 5070931709 5070216643 5090113203 5090103763 5090103771 5090104697 5090104700 5090104719 5090105030 5090105049 5090105057 5090106045 5090106053 5090106568 5090106584 5090106592 5090106606 5090110344 5090110352 5090112800 5060217876 5060217884 5070220144 5070218417 5070931687 5090113181 5090113173 5080103426 5060214044 5080119276 5080119284 5080110783 5080117206 5080119144 5080115483 5080121017 5080117532 5070219472 5080118911 5080108320 5090113548 5080107375 5020918865 5020919055 5080107405 5090113092 5080121963 540349 5050911664 5050911672 5070120134 5070120117 5050410843 5080119454 5080107367 5060218317 5050415063 5050910463 5080122404 5030334610 5080107499 3090900764 5090106460 5090106479 5090109648 457925 5030132252 5080121084 5060219208 5060218228 5060214206 5080116196 5070219405 5080121165 5030859349 5080115572 5080112905 5090111189 CRB1206112 5040916809 5090104298 5020915556 5090111804 5090111847 CRB1209129 508011444
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.