# FDA recall Z-1289-2018

> **Invivo Corporation** · Class II · device recall initiated 2018-01-24.

## 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 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.

## 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 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.

## Key facts

- **Recall number:** Z-1289-2018
- **Recalling firm:** Invivo Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-24
- **Report date:** 2018-04-11
- **Termination date:** 2020-05-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gainesville, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1289-2018

## Citation

> AI Analytics. FDA recall Z-1289-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1289-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*