Events

Device Recall 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
    73193
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0771-2016
  • 사례 시작날짜
    2016-01-22
  • 사례 출판 날짜
    2016-02-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-10-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143569
  • 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
    The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. if this failure occurs the gun box may become loose and could come into contact with a patient.
  • 조치
    Accuray sent an Urgent Safety Advisory Notification letters dated January 22, 2016 to all affected customers by trackable mail method. The letters identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Acknowledgement form. For questions contact Customer Support at 1-877-668-8667 or visit the Accuray Technical Solution Center at http://www.accuray.com/services-support

Device

Device Recall CyberKnife Robotic Radiosurgery System
  • 모델명 / 제조번호(시리얼번호)
    Catalog/part numbers 032000 and 033000; Serial numbers: United States: C0063 C0064 C0074 C0088 C0090 C0091 C0092 C0095 C0096 C0098 C0099 C0100 C0101 C0102 C0103 C0104 C0106 C0108 C0111 C0112 C0114 C0118 C0119 C0123 C0126 C0127 C0128 C0131 C0133 C0134 C0135 C0136 C0137 C0143 C0144 C0146 C0149 C0150 C0151 C0152 C0155 C0158 C0159 C0162 C0163 C0165 C0172 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 C0224 C0226 C0233 C0244 C0246 C0247 C0248 C0252 C0253 C0254 C0256 C0259 C0260 C0261 C0262 C0263 C0273 C0274 C0278 C0283 C0284 C0285 C0290 C0291 C0293 C0296 C0303 C0304 C0312 C0316 C0323 C0328 C0353 C0355 C0124: International:  C0170 C0171 C0180 C0216 C0236 C0264 C0269 C0326 C0204 C0125 C0175 C0189 C0191 C0215 C0227 C0279 C0315 C0166 C0147 C0168 C0187 C0105 C0242 C0185 C0286 C0306 C0188 C0218 C0237 C0240 C0265 C0268 C0288 C0314 C0324 C0251 C0272 C0322 C0153 C0289 C0235 C0267 C0120 C0138 C0148 C0157 C0212 C0229 C0239 C0297 C0241 C0281 C0300 C0307 C0308 C0313 C0320 C0327 C0329 C0331 C0333 C0340 C0341 C0347 C0350 C0392 C0115 C0117 C0154 C0161 C0228 C0255 C0266 C0270 C0294 C0339 C0176 C0195 C0309 C0319 C0321 C0093 C0221 C0234 C0249 C0275 C0277 C0299 C0305 C0325 C0110 C0113 C0130 C0232 C0245 C0276 C0287 C0295 C0217 C0282 C0107 C0258 C0271 C0280 C0298 C0301 C0302 C0310 C0317 C0357 C0365 C0202 C0231 C0238 C0230.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution. US Nationwide, Venezuela, United Kingdom, Ukraine, Turkey, Thailand, Taiwan, Switzerland, Spain, Saudi Arabia, Russia, Poland, Pakistan, Myanmar, Mexico, Korea, Japan, Italy, Ireland, India, Greece, Germany, France, Finland, Czech Republic, Colombia, China, Canada, and Belgium.
  • 제품 설명
    CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. || Product Usage: || The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
  • Manufacturer
    Accuray Incorporated

Manufacturer

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