Events

Device Recall Oncor Impression Plus Medical Linear Accelerator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Medical Solutions USA, Inc 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
    46940
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1397-2008
  • 사례 시작날짜
    2008-01-11
  • 사례 출판 날짜
    2008-04-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-05-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69043
  • 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
    Medical Linear Accelerator - Product Code IYE
  • 원인
    Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.
  • 조치
    This is a mandatory software upgrade for consignees. The firm's representatives have contacted consignees via Urgent Device Notification letters dated February 14, 2008, notifying them of the new update and making arrangements to install it.

Device

Device Recall Oncor Impression Plus Medical Linear Accelerator
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 4065 70-4306 3764 3964 3803 5093 70-4119 70-4144 70-4145 70-4177 70-4343 3801 70-4222 3955 70-4161 4019 5033 70-4142 4067 70-4122 3783 3901 3791 3793 70-4262 5096 3888 70-4172 70-4174 70-4317 70-4378 3802 3953 3804 70-4354 70-4356 3815 3948 70-4135 3753 3846 3907 3975 3998 3761 4072 3981 70-4166 4035 70-4345 70-4362 3989 70-4175 4015 70-4159 70-4157 70-4349 3877 3754 3755 70-4129 3769 3957 5060 70-4183 3778 5088 5098 3855 70-4379 4091 4011 70-4136 70-4154 70-4334 4024 3796 3799 3865 70-4361 3795 5034 5057 5059 5105 3808 4022 4068 4081 5032 5058 5086 5102 70-4132 70-4147 70-4149 70-4153 70-4189 70-4288 70-4331 70-4366 70-4158 3823 3965 5061 5091 70-4124 70-4137 70-4329 70-4348 5068 70-4215 70-4253 70-4272 70-4305 70-4335 70-4338 70-4176 70-4209 3816 4012 4053 70-4186 70-4241 70-4244 3858 3963 4002 4027 70-4346 4071 3836 3827 4005 5039 5040 70-4231 5030 70-4328 70-4365 4026 4009 3916 5084 70-4278 3925 3954 5027 5069 5104 70-4224 70-4295 70-4299 5101 704093 3968 4037 70-4193 70-4292 70-4127 3841 4062 4064 4074 5002 4017 4084 4096 5001 5011 5053 5087 5095 70-4107 5031 3983 5081 5085 5023 3776 3848 70-4097 70-4258 70-4301 5004 3863 and 4008
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide-USA including states of AL, AK, AZ, AR, CA, CO, DE, DC, FL, GA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MS, MO, MN, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, WV, WI, and WY and countries of Angola, Australia, Austria,Belgium,Brazil,Canada,Chile,Colombia,Costa Rica, Croatia,Cyprus,The Czech Republic,Denmark,DPR of Korea,El Salvador,France,Germany,Greece,Hungary,India,Iran,Ireland,Italy,Japan,Jordan,Malaysia,Mexico, The Netherlands,New Zealand,Norway,P.R. China,Pakistan,Peru,Philippines,Poland,Portugal,Republic of Korea,Romania,Russian Fed.Saudi Arabia,Singapore,Slovakia,South Africa,Spain,Sweden,Taiwan,Thailand,Trinidad,Tobago,Turkey, U.A.E.,Ukraine, The United Kingdom, and Venezuela
  • 제품 설명
    Oncor Impression Plus Medical Linear Accelerator, Material Number : 5857912, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA