Events

Device Recall TrueBeam Radiotherapy Delivery System 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
    61196
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1175-2012
  • 사례 시작날짜
    2012-01-30
  • 사례 출판 날짜
    2012-03-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-04-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107546
  • 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
    An anomaly has been identified with the respiratory gating software of truebeam. when importing breath-hold gating protocols, the gating thresholds can be reset to default values, rather than retaining the thresholds established during planning.
  • 조치
    Urgent Medical Device Correction/Urgent Field Safety Notices were sent on January 30, 2012 by certified mail to US and Canadian consignees. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** Varian Sales, Marketing and Service Organizations also were informed via letter the same day. The Field Safety Notice with customer distribution list was e-mailed to Varian International Customer Support Managers for translation (if necessary) to be sent to affected sites with return proof of notification to be sent to Varian. The notice informed users of the recommended actions. Questions were directed to the Varian Help Desk 1-888-827-4265 (US and Canada).

Device

Device Recall TrueBeam Radiotherapy Delivery System
  • 모델명 / 제조번호(시리얼번호)
    Model H19: Code numbers:  H191182,H191035,H191150,H191100,H191103,H191040,H191072,H191065, H191089,H191116,H191068,H191160,H191141,H191113,H191027,H191145, H191026,H191093,H191054,H191189,H191129,H191090,H191197,H191022,H191063,H191010,H191162,H191078,H191098,H191142,H191066,H191005,H191018,H191076,H191188,H191048,H191137,H191064,H191153,H191044,H191151,H191046,H191136,H191067,H191031,H191077,H191158,H191028,H191156,H191088,H191132,H191009,H191069,H191085,H191186,H191101,H191094,H191039,H191124,H191073,H191183,H191008,H191133,H191016,H191003,H191071,H191175,H191152,H191168,H191099,H191166,H191029,H191036,H191155,H191092,H191034,H191043,H191045,H191074,H191170,H191130,H191055,H191147,H191178,H191114,H191107,H191164,H191047,H191015,H191091,H191019,H191038,H191163,H191203,H191110,H191061, H191049,H191179,H191096,H191079,H191106,H191017,H191154,H191006,H191024,H191108,H191149,H191052,H191199,H191023,H191117,H191033,H191104,H191131,H191011,H191118,H191087,H191109,H191053,H191187,H191126,H191191,H191042,H191080,H191161,H191105,H191012,H191025, H191115,H191111,H191140,H191020,H191013,H191169,H191127,H191086,H191144,H191095,H191125,H191002,H191112,H191021,H191138,H191014,H191135,H191139,H191097,H191032,H191102,H191119,H191128,H191060,H191001,H191198,H191057,H191122,H191146,H191157,H191143,H191083,H191180,H191121,H191181,H191123,H191081,H191165,H191176,H191056,H191120,H191082,H191041,H191070,H191134,H191148,H191030,H191058,H191007,H191177,H191051,H191172,H191059 and H191037,  *** 12-12-12, AMENDED INFO ***:  H191167, H191171, H191184, H191185, H191192, H191194, H191202, H191205, H191207, H191208, H191211, H191214, H191217, H191219, H191220, H191222, H191223, H191224***
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution (USA) and the countries of Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Italy, Netherlands, New Zealand, Norway, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, Turkey and the United Kingdom.
  • 제품 설명
    TrueBeam and True Beam STx versions 1.0 through 1.5, Model number H19; Varian Medical Systems, Palo, Alto, CA 94304. TrueBeam Radiotherapy Delivery System is 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