Recall Z-1289-2018 ยท LLZ System, Image Processing, Radiological
Invivo Corporation
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.
| Date | Apr 2, 2018 (initiated Jan 24, 2018) |
| Status | Terminated |
| Reason | 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 cli |
| Root cause | Other |
| Action | Invivo sent an Urgent Medical Device Correction - Field Safety Notice letter dated January 24, 2018 to affected customers. The letter identified the affected product, problem and actions to be taken. This document contains important information for the continued safe and proper use of your equipment. Customers were instructed to review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication. Customers were asked to retain a copy with the equipment Instruction fo |
| Quantity | 470 distribution events, 232 actual units (updated 6/26/18) |
| Distribution | 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 ma |
| FDA record | Open on fda.gov |