Events

Device Recall DynaCad 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Invivo Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    79590
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1289-2018
  • 사례 시작날짜
    2018-01-24
  • 사례 출판 날짜
    2018-04-02
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162733
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    System, image processing, radiological - Product Code LLZ
  • 원인
    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.
  • 조치
    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

Device

Device Recall DynaCad
  • 모델명 / 제조번호(시리얼번호)
    (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
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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.
  • Manufacturer
    Invivo Corporation

Manufacturer

Invivo Corporation
  • 제조사 주소
    Invivo Corporation, 3545 SW 47th Ave, Gainesville FL 32608-7691
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA