Events

Siemens 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
    47773
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1769-2008
  • 사례 시작날짜
    2007-10-03
  • 사례 출판 날짜
    2008-08-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-04-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70134
  • 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
    Software. the firm issued an advisory letter update instruction th030/07/s as a result of a complaint that images viewed in the device may shift, which could result in mistreatment. the advisory alerts all its affected customers of the image issue to prevent potential mistreatment.
  • 조치
    Customer Safety Advisory Notice was issued on 10/03/2007 to consignees, via certified mail. Consignees are strongly cautioned that they should not further correct the image alignment at this time as doing so will result in incorrect offset values which could lead to incorrect repositioning of the patient. Consignees are instructed to check the "Filter Images on Loading" and "Saving of Filtered Images" config settings, and apply any additional filters to the image BEFORE using the interactive shift or landmark registration tools. Do not correct any perceived issues. A software fix is being validated and will be available soon.

Device

Siemens
  • 모델명 / 제조번호(시리얼번호)
    Software Numbers 7358299, 7360857, and 8141835. Applies only to those parts used with the following devices: Coherence AG Therapist-5863506; Coherence Therapist System-7333680; Coherence Impression Therapist-7341410; PRIMEVIEW 3i-7341428; AG Therapist 3rd party V&R-7351898; Coherence Therapist 2.0-8139839 and PRIMEVIEW 3i 2.0-8139847.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Class II Recall - Worldwide Distribution --- including USA and countries of Angola, Australia, Brazil, Canada, Croatia, Denmark, Egypt, France, Germany, Greece, Hungary, India, Iran, Italy, Japan, Malaysia, Netherlands, New Zealand, P.R. China, Poland, Portugal, Republic Korea, Russian, Fed. Saudi Arabia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad, Tobago, Turkey, United States, Vietnam.
  • 제품 설명
    Medical charged-particle radiation therapy system. Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.0 and Oncologist R2.0. Product update, TH 030//07/S. The COHERENCE Therapist R2.0 software numbers are: 7358299, 7360857, and 8141835 and applies only to those parts used with the following devices: Coherence AG Therapist; Coherence Therapist System; Coherence Impression Therapist; PRIMEVIEW 3i; AG Therapist 3rd party V&R; Coherence Therapist 2.0 and PRIMEVIEW 3i 2.0.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA