Events

Device Recall Xray Fluorescence 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Olympus Scientific Solutions Americas 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
    76208
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1036-2017
  • 사례 시작날짜
    2017-01-07
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152524
  • 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
    X-ray fluorescence - Product Code RBY
  • 원인
    It was discovered under rare circumstances the led warning light circuit could fail. if this happens, while the instrument is emitting x-rays during at test, the led warning lights will not illuminate. the test runs normally and will execute as before, but the light will not be on.
  • 조치
    Olympus will bring the defect compliance : 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office recall coordinator noted below are to be included in the notification. 2. Tracking of customer/owner self-installation(s) of the software update should be done to the maximum possible extent via serial-number-tracked downloads, follow-up email reporting, return-mail card or by other similarly effective means. For further questions, please call (781) 419-3500.

Device

Device Recall Xray Fluorescence
  • 모델명 / 제조번호(시리얼번호)
    affects all units.
  • 의료기기 등급
    Not Classified
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : PA, MA, CO, OH, NJ, GA, CA, TX, IL, VA, MN, NH, WA, SC, AZ, LA, MD, OK, IN, NY, NC and KS.
  • 제품 설명
    Olympus Scientific Solutions Americas Corporation || (OSSA) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR || Analytical X-ray systems
  • Manufacturer
    Olympus Scientific Solutions Americas

Manufacturer

Olympus Scientific Solutions Americas
  • 제조사 주소
    Olympus Scientific Solutions Americas, 48 Woerd Ave, Waltham MA 02453-3824
  • 제조사 모회사 (2017)
    Olympus Corporation
  • Source
    USFDA