Events

Device Recall Accuray CyberKnife Robotic Radiosurgery System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Accuray Incorporated 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
    67278
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0828-2014
  • 사례 시작날짜
    2014-01-13
  • 사례 출판 날짜
    2014-01-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-11-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125140
  • 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
    Accelerator, linear, medical - Product Code IYE
  • 원인
    Potential safety issue with synchrony boom arm mounting assembly - one complaint of mounting assembly detaching.
  • 조치
    Urgent Medical Device Correction notification letter were sent out beginning January 14, 2014 by trackable method. Letters describe potential problem and provide inspection instructions to be performed prior to use.

Device

Device Recall Accuray CyberKnife Robotic Radiosurgery System
  • 모델명 / 제조번호(시리얼번호)
    Part number: 054000-001; Serial numbers in US: C0022 C0030 C0037 C0042 C0045 C0046 C0047 C0048 C0049 C0051 C0052 C0053 C0055 C0056 C0057 C0058 C0059 C0061 C0062 C0063 C0064 C0067 C0068 C0070 C0071 C0072 C0074 C0078 C0079 C0080 C0088 C0090 C0091 C0092 C0094 C0095 C0097 C0098 C0099 C0100 C0101 C0102 C0103 C0106 C0108 C0109 C0111 C0112 C0114 C0118 C0119 C0122 C0123 C0126 C0127 C0128 C0131 C0132 C0133 C0134 C0135 C0136 C0137 C0139 C0141 C0143 C0144 C0146 C0149 C0150 C0151 C0152 C0155 C0158 C0159 C0160 C0162 C0163 C0165 C0174 C0177 C0178 C0179 C0181 C0182 C0183 C0184 C0186 C0192 C0194 C0196 C0197 C0198 C0199 C0200 C0201 C0203 C0205 C0206 C0207 C0208 C0209 C0210 C0213 C0214 C0219 C0220 C0222 C0223 C0224 C0225 C0226 C0233 C0243 C0244 C0246 C0247 C0248 C0252 C0253 C0254 C0256 C0257 C0259 C0260 C0261 C0262 C0263 C0273 C0274 C0278 C0283 C0284 C0285 C0290 C0291 C0293 C0296 C0303 C0304 C0312 C0316 C0323 C0332 C0335 C0336 C0338 C0343 C0124 Out of US: C0202 C0231 C0238 C0351 C0170 C0171 C0235 C0267 C0282 TBD C0032 C0054 C0060 C0093 C0105 C0110 C0113 C0115 C0117 C0125 C0130 C0154 C0161 C0175 C0176 C0180 C0185 C0187 C0188 C0189 C0191 C0195 C0204 C0211 C0215 C0216 C0217 C0218 C0221 C0227 C0228 C0230 C0232 C0234 C0236 C0237 C0240 C0242 C0245 C0249 C0251 C0255 C0264 C0265 C0266 C0268 C0269 C0270 C0272 C0275 C0276 C0277 C0279 C0286 C0287 C0288 C0292 C0294 C0295 C0299 C0305 C0306 C0309 C0314 C0315 C0319 C0321 C0322 C0324 C0325 C0326 C0330 C0334 C0337 C0339 C0342 C0344 C0348 C0349 C0006 C0007 C0008 C0012 C0013 C0014 C0019 C0020 C0033 C0190 C0193 C0241 C0281 C0300 C0307 C0308 C0313 C0320 C0327 C0329 C0331 C0333 C0340 C0341 C0347 C0038 C0041 C0065 C0073 C0075 C0076 C0077 C0084 C0085 C0086 C0087 C0089 C0107 C0120 C0121 C0138 C0140 C0145 C0147 C0148 C0157 C0166 C0168 C0169 C0173 C0212 C0229 C0239 C0258 C0271 C0280 C0289 C0297 C0298 C0301 C0302 C0310 C0317 C0345.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution. - US (Nationwide) and Mexico; and Internationally to: Australia, Belgium, Canada, China, Colombia, Czech Republic, England, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Korea, Malaysia, Luxembourg, Netherlands, Poland, Russia, Saudia Arabia, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Venezuela, and Vietnam
  • 제품 설명
    Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. || Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.
  • Manufacturer
    Accuray Incorporated

Manufacturer

Accuray Incorporated
  • 제조사 주소
    Accuray Incorporated, 1310 Chesapeake Ter, Sunnyvale CA 94089-1100
  • 제조사 모회사 (2017)
    Accuray Inc
  • Source
    USFDA