Events

Device Recall Siemens syngo RT Dosimetrist 2.7 system 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
    68395
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2075-2014
  • 사례 시작날짜
    2014-05-15
  • 사례 출판 날짜
    2014-07-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-12-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127508
  • 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
    System,planning,radiation therapy treatment - Product Code MUJ
  • 원인
    An update to the virtual simulation software of the syngo rt dosimetrist is necessary to address a safety issue. in special scenarios within the structure operations function the system did not store the selected name from the list of predefined names. after reloading of the data, this structure name had been changed by the system. additionally, a performance issue was addressed where import of di.
  • 조치
    Siemens sent a Medical Device Correction Field Safety Notice of Improvement letter to affected customers via USPS Certified Mail. The letter described the affected product, problem, and actions to be taken.

Device

Device Recall Siemens syngo RT Dosimetrist 2.7 system
  • 모델명 / 제조번호(시리얼번호)
    material number: 10568604 , with serial numbers 10201 10231 10237 10266 10267 10305 10272
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution in the states of NH, TN, OH, VA, and TX.
  • 제품 설명
    Siemens syngo RT Dosimetrist 2.7 system || Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray radiation for the therapeutic treatment of cancer.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA