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U.S. Department of Health and Human Services

Class 2 Device Recall DynaCad

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  Class 2 Device Recall DynaCad see related information
Date Initiated by Firm January 24, 2018
Date Posted April 02, 2018
Recall Status1 Terminated 3 on May 04, 2020
Recall Number Z-1289-2018
Recall Event ID 79590
510(K)Number K121517  K133030  
Product Classification System, image processing, radiological - Product Code LLZ
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.
Code Information (Added 6/26/18:) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 205 206 207 208 209 210 211 221 222 223 224 225 226 228 229 230 DCAD1600760 DCAD1600796 DCAD1600860 DCAD1600879 DCAD1700886 DCAD1700891 DCAD1700905 DCAD1700913 DCAD1700913-1 DCAD1700913-2 DCAD1700913-3 DCAD1700913-4 DCAD1700913-5 DCAD1700928 DCAD1700930 
Recalling Firm/
Manufacturer		 Invivo Corporation
3545 SW 47th Ave
Gainesville FL 32608-7691
For Additional Information Contact
352-336-0010
Manufacturer 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.
FDA Determined
Cause 2		 Other
Action 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
Quantity in Commerce 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 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = ICAD, INC.
510(K)s with Product Code = LLZ and Original Applicant = INVIVO CORPORATION
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