DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of Dyn...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1289-2018.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1289-2018.
Recall terminated by FDA.
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Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1289-2018.
Invivo Corporation
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Invivo Corporation Recall FAQ
Invivo Corporation is the subject of a medical devices safety report: DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of Dyn.... The notice was published on January 24, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 470 units are potentially affected.