Vital Images Recalls VitreaCore Software Due to Image Orientation Defect
Vital Images, Inc. is recalling VitreaCore software versions 6.0 through 6.5 due to a potential for incorrect or reversed image orientation in certain snapshots.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical diagnostic software) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Vital Images, Inc. has identified an issue in VitreaCore software through internal testing. The recall affects software versions 6.0, 6.1, 6.2, 6.3 (except 6.3.1), 6.4 (except 6.4.4 and 6.4.5), their upgrades, and 6.5.
The defect presents a potential for incorrect and possibly reversed image orientation for certain snapshots taken within the software. VitreaCore is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images from various imaging devices.
The recall involves 598 units distributed nationwide in the continental United States (excluding Oklahoma and Rhode Island) and in numerous international locations. Users of the affected software versions should contact Vital Images, Inc. for further instructions regarding the limitation.
The recalled product
- Product
- VitreaCore¿ software. Versions subject to the limitation: 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. The VitreaCore (ViTALConnect) system is a medical diagnostic software system intended to process, analyze…
- Manufacturer
- Vital Images, Inc.
- Hazard
- Affected units
- 598
Distribution
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