DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software

FDA device recall Z-1289-2018 · posted 2018-04-02 · Terminated

Recall details

Recalling firm

Invivo Corporation

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.

Action taken

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 for Use. For questions contact Invivo Customer Support: 1-877-468-4861 Opt. 3

Root cause

Other

Status

Terminated

Product code

LLZ

Quantity affected

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 compute

Date initiated

2018-01-24

Date posted

2018-04-02

Date terminated

2020-05-04

Location

Gainesville, FL

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