Invivo recalls DynaCad software updates 3.5 causing incorrect pharmacokinetic and diffusion maps. Users may underestimate critical medical values. No remedy stated.
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.
Invivo Corporation is recalling DynaCad software updates 3.5 due to incorrect display of pharmacokinetic and diffusion maps. This could lead to underestimating important medical values like Ktrans and ADC, potentially affecting diagnosis.
After updating DynaCad software from version 3.3 to 3.5, the software incorrectly displays pharmacokinetic (PK) color maps and diffusion coefficient (ADC) maps when viewed remotely. This could cause medical professionals to underestimate critical values like Ktrans, Kep, and iAUGC, which are important for accurate diagnosis.
Users of DynaCad software for medical imaging analysis who updated to version 3.5 may be affected. Medical professionals using the software for MRI analysis are most at risk.
Check if you updated DynaCad software from version 3.3 to 3.5. The affected software includes DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK modules.
Verify your DynaCad software version to see if it has been updated from 3.3 to 3.5.
The update from 3.3 to 3.5 caused incorrect display of pharmacokinetic and diffusion maps, which could lead to underestimating critical medical values.
Software updated from version 3.3 to 3.5, including DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK modules.
The recall record does not state a remedy or fix for this issue.
We’ve drafted a message you can send Invivo to request your refund or repair — edit it as you like.
Subject: Recall Z-1289-2018 — Invivo Invivo Hello, I own a Invivo that is covered by recall Z-1289-2018 from Invivo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
