Events

Device Recall HighDefinition 120 MultiLeaf Collimator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Varian Medical Systems 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
    46852
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1459-2008
  • 사례 시작날짜
    2008-01-30
  • 사례 출판 날짜
    2008-08-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-08-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68342
  • 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 charged-particle radiation therapy system - Product Code IYE
  • 원인
    Dose calculation error: software anomaly may result in failure of a mlc leaf to reach planned position, potentially resulting in misadministration of dose to a patient.
  • 조치
    Consignees were notified by a Medical Device Notification letter sent on 01/29/2008. The letter advised users to cease use of the device until a corrected version of the software is available. A representative will contact users to upgrade the application once the revised software has been validated and released for distribution.

Device

Device Recall HighDefinition 120 MultiLeaf Collimator
  • 모델명 / 제조번호(시리얼번호)
    Serial Number 1009.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including states of NC, FL and CA.
  • 제품 설명
    High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy system; Software Version 7.0; Product Code: H56; Accessory to Medical Linear Accelerator.
  • Manufacturer
    Varian Medical Systems Oncology Systems

Manufacturer

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