Events

TrueBeam and TrueBeam STx, 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Varian Medical Systems, Inc. Oncology Systems 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
    60411
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0364-2012
  • 사례 시작날짜
    2011-10-31
  • 사례 출판 날짜
    2011-12-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105265
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
    Accelerator, linear, medical - Product Code -IYE
  • 원인
    An anomaly has been identified with the truebeam and truebeam stx systems where, under certain tuning conditions, the electron beam emerging from the bend magnet may have an elongated spot shape.
  • 조치
    On 11/04/2011, an Urgent Medical Device Correction Letter was distributed to all affected users, with a description of the problem and user corrective action steps. Varian is developing a corrective action for this issue. A customer service representative will contact you when the correction is available to schedule installation on your system. Questions regarding the letter should be directed to the Varian Oncology Help Desk Contact Information at USA and Canada: 1-888-827- 4265 or Europe +41-41-749-8844.

Device

TrueBeam and TrueBeam STx,
  • 모델명 / 제조번호(시리얼번호)
    Model numbers: H191113, H191034, H191105, H191154, H191046, H191053, H191044, H191015, H191035, H191108, 191152, H191140, H191069, H191017, H191027, H191109, 191130, H191002, H191071, H191024, H191078, H191111, 191072, H191102, H191074, H191087, H191151, H191125, 191018, H191058, H191038, H191115, H191085, H191032, 191077, H191023, H191103, H191095, H191163, H191146, 191124, H191138, H191093, H191097, H191040, H191030, 191029, H191060, H191066, H191122, H191054, H191126, 191114, H191082, H191067, H191081, H191005, H191013, 191116, H191051, H191094, H191052, H191031, H191021, 191048, H191139, H191099, H191020, H191039, H191128, 191156, H191057, H191061, H191112, H191049, H191083, 191008, H191123, H191065, H191119, H191089, H191120, 191092, H191134, H191129, H191056, H191090, H191033, 191047, H191037, H191076, H191007, H191028, H191080, 191106, H191118, H191073, H191117, H191155, H191086, 191141, H191025, H191036, H191042, H191079, H191135, 191010, H191100, H191107, H191127, H191063, H191070, 191153, H191026, H191096, H191014, H191064, H191059, 191009, H191142, H191068, H191001, H191132, H191011, 191003, H191136, H191022, H191121, H191016, H191012, 191045, H191101, H191088, H191041, H191043, H191150, 191019, H191055, H191133, H191131, H191091, H191098, 191006 and H191110
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution including the US and Internationally.
  • 제품 설명
    TrueBeam and TrueBeam STx, Model Number: H19, Ref/FSCA identifier: CP-06381 are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

Varian Medical Systems, Inc. Oncology Systems
  • 제조사 주소
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • 제조사 모회사 (2017)
    Varian Medical Systems Inc
  • Source
    USFDA