Vital Images Recalls Vitrea CT Cardiac Analysis Software Due to Data Errors
Vital Images is correcting a defect in the Vitrea CT Multi-Chamber Cardiac Functional Analysis application where numerical values in the Results Table may be incorrect.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a data accuracy defect without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary correction.
Plain-English summary
Vital Images, Inc. is performing a field correction on the Vitrea CT Multi-Chamber Cardiac Functional Analysis application. This software provides tools for analyzing clinical CT images of the coronary arteries, heart, and surrounding tissue. The recall affects versions 5.2 through 6.4 of the Vitrea workstation and related suites.
The defect involves the potential for numerical values to be incorrect in the 'Results Table' under the 'Cardiac Analysis' portion of the user interface. Vital Images identified this issue and initiated the field correction to address the data accuracy problem.
The affected units were distributed worldwide, including in the United States and various international locations. Users of the affected software versions should contact Vital Images for information regarding the field correction.
The recalled product
- Product
- Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite, through version 6.4. Vitrea¿ CT Multi-Cham
- Manufacturer
- Vital Images, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 102
Distribution
Related recalls
Same manufacturer · Vital Images, Inc.
See all →- HighVital Images Recalls VitreaCore Software Due to Image Orientation Defect
FDA (Devices) · 2013-11-13
- HighVital Images Recalls Vitrea CT Brain Perfusion Software Due to User Confusion
FDA (Devices) · 2013-05-08
- HighVital Images Recalls Vitrea Software Due to Measurement Errors
FDA (Devices) · 2013-04-03
- HighVital Images Recalls Vitrea Software Due to Calcium Score Errors
FDA (Devices) · 2012-11-07
Same hazard · data error
See all →- HighBar Code Reader Wands for GEM Premier Blood Analyzers Recalled Due to Misidentification Risk
FDA (Devices) · 2026-08-05
- ModerateBiomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors
FDA (Devices) · 2020-03-04
- HighBiomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors
FDA (Devices) · 2020-03-04
- SeverePerkinElmer Specimen Gate Screening Center Software Recall for Data Errors
FDA (Devices) · 2018-05-09
- SeverePerkinElmer Recalls Specimen Gate Laboratory Software Due to Data Errors
FDA (Devices) · 2017-04-19