Events

Device Recall Toshiba Kalare DREX KL80 Xray generator 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
    76175
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1397-2017
  • 사례 시작날짜
    2016-05-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-06-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152449
  • 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
    It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination.
  • 조치
    Toshiba America Medical Systems planned action to bring defect into compliance : 1. A notification letter will be sent to customers with affected systems. This letter includes the statement that the repairs will be made at no cost to the customer. 2. Modified firmware will be installed on the systems to prevent the defect from recurring. 3. The consignees will be contacted by a Toshiba service representative for an appointment when the modified firmware becomes available 4. The consignee will be informed that if this problem occurs before the new firmware is installed; they should reset the x-ray generator to complete the exam; and 5. The CAP will be completed by May 1, 2017. For further questions please call (714) 730-5000

Device

Device Recall Toshiba Kalare DREX KL80 Xray generator
  • 모델명 / 제조번호(시리얼번호)
    Model : KXO-80XD
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA ( nationwide ) Distribution to the states of : WA, OR, CA, OH, IL, CT, IA, KY, AL, LA, HI, PA, NJ, DE, MN, DC, NY, MI, SC, MD, TN, OK, WI, UT, ID, NV, TX, AL, IN, WV, KS, MO, CO, MT, MS, NC, GA, NH,UT, FL, AZ and ND.
  • 제품 설명
    Toshiba Kalare DREX-KL80 X-ray generator
  • 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