Events

Syngo RT Oncologist 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
    71979
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0106-2016
  • 사례 시작날짜
    2015-08-11
  • 사례 출판 날짜
    2015-10-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139481
  • 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
    This update is intended to provide a software update for the syngo rt oncologist, which is currently running sw version 4.2 or 4.3. the safety-related issues, which were described in the customer safety notice distributed as ufsn-rtt/rto 4.3 adaptive targeting [auto-registration]. the update contains several important safety and performance fixes.
  • 조치
    The firm, Siemens, sent Recall letters, dated August 2015, that describe the product, the problem, and correction, will be hand-delivered to affected sites at the time the fix is implemented by a Siemens technician. If you have any questions, contact Regulatory Technical Specialist at 610-448-6471 or email: marlynne.galloway@siemens.com

Device

Syngo RT Oncologist
  • 모델명 / 제조번호(시리얼번호)
    Model Number of device- 10568604, serial numbers: 10206 10337 10338 10100 10289 10197 10131 10179 10184 10158 10235 10236 10080 10296
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to states of: MA, MO, OH, PA, UT, and WI.
  • 제품 설명
    Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Mail Code: 65-1A, Malvern PA 19355-1418
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA