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 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, D, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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 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- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Vital Images, Inc.
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 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, D, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography.
Product Codes/Lot Numbers:
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5080108932 5070931172 5080109041 5080119152 5050911796 5050911818 5050412102 5050910412 5050910420 5050910897 5050913985 5080118733 5080110619 5080110627 5060213692 5060213722 5060214486 5080114894 5080114908 5060216608 5090111731 5080123303 5090109362 5080119438 5080119500 5080110406 5090104530 5050913691 5070932489 5070932446 5070932454 5070932462 5090111650 5090111669 5090105073 5090105081 5090112274 5080115602 5080115610 5050911710 5060213838 5080114517 5080116013 5050913438 5080116994 5070216740 5080108622 5080113391 5080110635 5090105472 CRU1111023 5030857605 5070931776 5060218406 5080110880 5050413257 392039 5080118490 542061 5070120780 5070933876 5080102756 5050911478 5090103410 CRU1108017 5080112751 5080121920 5080102861 5070221248 5050413699 J2924511641 5080115394 5060214540 5031218355 5080123192 5090102619 5020915122 5070934449 5070219960 5030334157 5080113472 5031217170 UNK157892 5060219038 5060220745 UNK145207 UNK145210 5050311780 5070222287 5070222295 5090109168 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Distribution:
Distributed in: DC, PR
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1002-2013
Related Recalls
Vital Images, Inc. has found an issue in VitreaCore software though internal testing. There is a potential for incorrect and possibly reversed image orientation for certain snapshots taken in VitreaCore software versions 6.0, 6.1, 6.2, 6.3 (except 6.3.1), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5.
Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D when the scan was performed using a wide coverage shuttle acquisition technique. This may result in patient treatment delays, misdiagnosis or mistreatment.
Vital Images has made a decision to perform a field correction to the Vitrea CT Multi-Chamber Cardiac Functional Analysis application. Vital Images has identified a defect in which numerical values may be incorrect in the Results Table under the Cardiac Analysis portion of the user interface.