Events

System, xray, mobile 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Shimadzu Medical Systems 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
    62271
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0265-2013
  • 사례 시작날짜
    2011-10-28
  • 사례 출판 날짜
    2012-11-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-07-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110041
  • 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, mobile - Product Code IZL
  • 원인
    Shimadzu is recalling diagnostic x-ray beam-limiting device, mobile x-ray system and diagnostic x-ray tube assembly because they do not comply with the product performance standards, 21cfr 1020.30 (m) beam quality --(1) half-value layer (hvl), which was revised in 2006. certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
  • 조치
    Shimadzu sent an Urgent Voluntary Medical Device Recall - Field Safety Notice letters dated September 19, 2012 to all the affected customers. The letter identifed the description of non-compliance, how to identify the affected products, corrective action plan by Shimadzu and actions to be taken customers. Customers were instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at Shimadzu Medical Systems National Technical Support (800) 228-1429.

Device

System, xray, mobile
  • 모델명 / 제조번호(시리얼번호)
    S/N of X-ray tube: 2XY0084725 2XY0084724 2XY0084723 2XY0099698 2XY0084726 2XY0084736 2XY0084739 2XY0084869 2XY0084729 2XY0084868 2XY0085162 2XY0085175 2XY0086383 2XY0086395 2XY0086726 2XY0086725 2XY0086724 2XY0087086 2XY0087088 2XY0087090 2XY0087421 2XY0087423 2XY0087427 2XY0087765 2XY0090747 2XY0091075 2XY0093894 2XY0096298 2XY0096820 2XY0096821 2XY0096832 2XY0096292 2XY0098245 2XY0098240 2XY0001064 2XY0001195 2XY0001088 2XY0001208 2XY0001077 2XY0001086 2XY0001198 2XY0001321 2XY0001204 2XY0001336 2XY0001337 2XY0001352 2XY0001388 2XY0001315 2XY0001370 2XY0001380 2XY0001464 2XY0001482 2XY0001484 2XY0001485 2XY0002730 2XY0003042 2XY0003037 2XY0003759 CM74B3016024 CM74B3017067 CM74B301201A CM74B3012018 CM74B3012017 CM74B301201C CM74B3012020 CM74B3012034 CM74B3012032 CM74B3013002 CM74B3016073 CM74B3016109 CM74B3015010
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    0.4/0.7JG326D-265AX/AT || Product Usage: || The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
  • Manufacturer
    Shimadzu Medical Systems

Manufacturer

Shimadzu Medical Systems
  • 제조사 주소
    Shimadzu Medical Systems, 20101 S Vermont Ave, Torrance CA 90502-1328
  • 제조사 모회사 (2017)
    Shimadzu Corp.
  • Source
    USFDA