Events

Kalare (DREXKL80) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Toshiba American Medical Systems 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
    78166
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0012-2018
  • 사례 시작날짜
    2017-09-12
  • 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=158813
  • 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
    System, x-ray, fluoroscopic, image-intensified - Product Code JAA
  • 원인
    During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk.
  • 조치
    Toshiba planned action to bring defect into compliance: 1. You will issue a Customer Notification Letter to make customers aware of the hazards, what measures will be taken to remedy the defect at no cost to the user, and how to safely use the equipment before corrections can be made. 2. You will install modified firmware on the systems to correct the defect and prevent recurrence. 3. You will provide progress reports on the effectiveness of the plan. CDRH approves the CAP subject to the following conditions: 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 coordinator are to be included in the notification. Thank you for your urgent attention to this matter. If you have any questions regarding this letter please feel free to call (800) 421-1968, or contact your local Toshiba Representative at (800) 521-1968. For further questions please call (714) 730-5000.

Device

Kalare (DREXKL80)
  • 모델명 / 제조번호(시리얼번호)
    Model: HDR-08A
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA (nationwide) Distribution
  • 제품 설명
    Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) || Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by qualified/trained doctors or technologists on both adult and pediatric subjects taking radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in prone or supine positions.
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • 제조사 주소
    Toshiba American Medical Systems Inc, PO Box 2068, 2441 Michelle Dr, Tustin CA 92780-7047
  • 제조사 모회사 (2017)
    Canon Inc
  • Source
    USFDA