FDA Devices recall · Reported April 11, 2018
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.
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 …
Invivo Corporation recalled DynaCad software consist of an MR Analysis Server software and the viewer workstation sof… - a moderate-severity action.
DynaCad software consist of an MR Analysis Server software and the viewer workstation sof… was recalled by Invivo Corporation in April 11, 2018. Reason: Following update from 3.3 to 3.5 of the DynaCAD software it was noted that the Ktrans map was not rendered co…. Check the official notice for the remedy. Verify recall #Z-1289-2018 with the FDA Devices before acting.
The recall
Invivo Corporation issued this moderate-severity FDA Devices recall-Following update from 3.3 to 3.5 of the DynaCAD software it was noted that the Ktrans map was not rendered co….
- Moderate
- severity level
- Class II
- classification
- April 11, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1289-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1289-2018 |
| Date reported | April 11, 2018 |
| Date initiated | January 24, 2018 |
| Recalling firm | Invivo Corporation |
| Firm location | Gainesville, FL |
| Affected scope | 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 re… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1289-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Similar severity · nearest report date
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Methodology · Corrections · Archive as of August 2026