Events

Device Recall Shimadzu SONIALVISION G4 Xray TV System 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
    75833
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0917-2017
  • 사례 시작날짜
    2016-11-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-12-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151433
  • 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
    Shimadzu medical systems is recalling shimadzu x-ray tv system sonialvision due to possibility of oil leaking from the x-ray tube housing under certain conditions.
  • 조치
    An urgent medical device recall notice and a field safety notice dated 11/20/16 was sent to customers to inform them that Shimadzu Corporation has identified a potential issue in the Shimadzu X-ray TV System SONIALVISION G4. Shimadzu informed their customers that they have received a report that oil had leaked from X-ray tube device of SONIALVISION G4 during examination. Customers are informed of the description of the issue, the actions planned by Shimadzu to correct the issue, and the actions that should be taken by the customer. Customers are instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at (800) 228-1429.

Device

Device Recall Shimadzu SONIALVISION G4 Xray TV System
  • 모델명 / 제조번호(시리얼번호)
    Serial No. 41C351641002 41C351643001 41C351641003 41C351641001 41C351646001 41C351646002 41C351647001 41C35164A001 41C35164B001 41C35164C001 41C351651001 41C351651002  41C351653003 41C351653002 41C351653004 41C351653005 41C351654002 41C351655001 41C351655002 41C351655003 41C351656001  41C351659001 41C35165A001 41C35165A002 41C35165A003 41C35165B001 41C35165B002 41C351661001 41C351661002 41C351662001 41C351663001 41C351663002 41C351664001 41C351664002 41C351664004 41C351664005 41C351665001 41C351665003 41C351665002
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US: TX, NY, SD, PA, MD, OH, IA, IN, MT, IL, FL, SC, OR, CA, AR, GA, CT, NV, PA, NE, WA
  • 제품 설명
    Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
  • 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