Events

Device Recall CIOS ALPHA 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
    73605
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1278-2016
  • 사례 시작날짜
    2016-02-19
  • 사례 출판 날짜
    2016-03-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144566
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • 원인
    Software issues on cios alpha mobile c-arm system.
  • 조치
    Siemens sent an Customer Safety Advisory Notice on February 26, 2016, to inform them of some issues that may arise on the Cios Alpha unit. The letter identified the product the problem and the action needed to be taken by the customer. Users were instructed to change the date format to DDMMYYYY to prevent issues, not to release radiation as long as the DVD icon is blinking and to disconnect and re-connect the trolley if the system is needed immediately. In the meantime they are preparing a modification of Cios Alpha that will resolve the above-mentioned issues. As soon as the modification is available, a service engineer will get in touch with each customer and implement the modification to the Cios Alpha system free of charge. If the device was sold, customers were instructed to forward the recall notification to the new owner. For further questions please call (610) 448-6478.

Device

Device Recall CIOS ALPHA
  • 모델명 / 제조번호(시리얼번호)
    Model # 10308191
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to the states of : AL, AR, CA, CO, CT, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA and WI
  • 제품 설명
    Cios Alpha, mobile X-ray system
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

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