Invivo DynaCAD Software Recalled for Incorrect Pharmacokinetic Map Display
Invivo Corporation is recalling DynaCAD software versions 3.4 and 3.5 because pharmacokinetic and ADC maps may display incorrectly on remote clients, potentially leading to underestimated values.
What this means for you
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. The hazard involves incorrect data display in medical software which could lead to misinterpretation of diagnostic results, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Invivo Corporation is recalling DynaCAD software, a post-processing package used for analyzing MRI datasets. The recall affects software versions 3.4 and 3.5. The product consists of an MR Analysis Server and viewer workstation software, including modules for breast, prostate, and other MR analyses.
The recall is due to a defect identified after a software update from version 3.3 to 3.5. The defect causes pharmacokinetic (PK) color maps to display incorrectly when viewed from remote DynaCAD client computers. This error could result in the visual underestimation of calculated Ktrans, Kep, and iAUGC values. Additionally, the defect impacts the on-the-fly calculation of Apparent Diffusion Coefficient (ADC) maps; if computed by DynaCAD, these values and colors will also display incorrectly on remote clients.
Users are advised to discontinue the use of Ktrans, Kep, and iAUGC colormaps when assessing studies from remotely connected DynaCAD client computers. Users should also refrain from using colormaps and values derived from ADC maps calculated by DynaCAD. Instead, users should utilize ADC maps originating natively from the MRI system, as these values are unaffected by the defect. Invivo Corporation will provide a v4.0 software update to correct the defect at no charge to the user.
The recalled product
- Product
- DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for other MR analyses modules. Product Usage: Intended to be used as a post processi
- Manufacturer
- Invivo Corporation
- Category
- Medical Device — Software
Distribution
Distribution scope not specified by the agency.
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