Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DynaCad software consist of an MR Analysis Server software and Recalled by Invivo Corporation Due to Following update from 3.3 to 3.5 of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Invivo Corporation directly.
Affected Products
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 processing software package designed to provide a reliable means for analyzing MR datasets.
Quantity: 470 distribution events, 232 actual units (updated 6/26/18)
Why Was This Recalled?
Following update from 3.3 to 3.5 of the DynaCAD software it was noted that the Ktrans map was not rendered correctly on the DynaCad Client. The defect causes the pharmacokinetic (PK) color maps to display incorrectly when viewed from remote DynaCAD client computers and could result in visually underestimating calculated Ktrans, Kep, and iAUGC values. The defect also impacts DynaCAD s on-the-fly calculation of Apparent Diffusion Coefficient (ADC) maps. If the ADC values are computed on-the-fly by DynaCAD, the ADC values and colors will also display incorrectly if viewed on a remote DynaCAD client.
Where Was This Sold?
Device is software. Customer notification letters recommended that users discontinue use of the Ktrans, Kep, and iAUGC colormaps when assessing studies from a remotely connected DynaCAD client computer. It is further advised that users refrain from using the colormaps and values derived from ADC maps calculated by DynaCAD. ADC maps originating natively from the MRI system should be used as an alternative as these values are unaffected. Firm will provide a v4.0 software update for the affected software versions (v3.4, v3.5) to correct the defect at no charge to the user.
About Invivo Corporation
Invivo Corporation has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report