Events

ARTISTE syngo RT Therapist 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
    53329
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0121-2010
  • 사례 시작날짜
    2009-09-10
  • 사례 출판 날짜
    2009-11-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-12-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85282
  • 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 Linear Accelerator - Product Code IYE
  • 원인
    A failed data transfer is possible that may result in data not being recorded in the interfaced system. siemens medical solutions, inc. usa became aware of this potential issue with its artiste linear accelerator's syngo rt therapist v4.1 workspace (containing the siemens brand of verify and record application called primeview) and the lantis oncology information system product.
  • 조치
    The firm issued a TH015/09/S Safety Modification syngo RT Therapist 4.1 Customer Advisory letter, dated September 10. 2009. the letter stated the reason for modification, the affected systems, working time, deadline, reimbursement, and reporting. The firm is preparing a software upgrade for the affected products to correct the problem. The letter was sent via certified mail.

Device

ARTISTE syngo RT Therapist
  • 모델명 / 제조번호(시리얼번호)
    Product: syngo RT Therapist model/part #8162815 Product: syngo RT Therapist Assist model/part #8162807 Product: syngo RT Therapist Express Basic model/part #8151289 Product: syngo RT Therapist Express Assist model/part #8151289
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Spain, Germany, Poland, Australia, Malaysia, New Zealand, the UK, India, Ireland, Egypt, Italy, Belgium, Republic of Korea, and Canada.
  • 제품 설명
    Siemens ARTISTE syngo RT Therapist, Therapist Assist, Therapist Express Basic, and Therapist Express Assist Systems, manufactured by Siemens Medical Solutions, Concord, CA
  • 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