Events

R30H, Diagnostic Xray Beam Limiting Device 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-0260-2013
  • 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=110036
  • 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
    Collimator, manual, radiographic - Product Code IZW
  • 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

R30H, Diagnostic Xray Beam Limiting Device
  • 모델명 / 제조번호(시리얼번호)
    Device Model #R-30H
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    R-30H , Diagnostic X-Ray Beam-Limiting Device. || In combination with any of below X-ray tubes || 0.6/1.2P364DK-85, 0.6/1.2P324DK-125, || 0.6/1.2P324DK-85, 0.6/1.2P38DE-85 || Device Model # R-30H. || Subsequent Product Code: IZX || Product Usage: || The device is the beam-limiting device for X-ray Radiography.
  • 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