Recall Z-1289-2018— Invivo Corporation

Name: FDA recall Z-1289-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-24

Class II · Terminated

Class II FDA medical device recall by Invivo Corporation, initiated 2018-01-24, terminated 2020-05-04. It names 2 FDA 510(k) clearances: K133030, K121517. 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 processing software package designed to provide a reliable means for analyzing MR datasets.. 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 client..

Recalling firm: Invivo Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-01-24
Terminated: 2020-05-04
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

2 on FDA's record

K133030 — DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)Invivo Corporation·cleared 2014-01-22
K121517 — VERSAVUE ENTERPRISE SUITEIcad, Inc.·cleared 2012-07-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.