Events

Device Recall Phoenix x/ray analyser series 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Inspection Technologies, LP 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
    52193
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1825-2011
  • 사례 시작날짜
    2009-03-16
  • 사례 출판 날짜
    2011-04-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82487
  • 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
    cabinet x-ray explosive detection systems - Product Code RCE
  • 원인
    Some of the systems do not have a safety interlock on the service access panel. although the systems have two independent means for indicating when x-rays are being generated, some systems may have one indicator that is not discernible. also, some systems lack proper placement of a caution label and others do not have this label affixed.
  • 조치
    The firm has completed all of the following necessary actions and no further actions have been indicated: A Field Service Memo was issued to customers. It described the affected product and described the issue. GE Sensing and Inspection provided and installed retrofit kits, and the systems in question were tested by qualified Field Service Engineers at no charge to customers. GE asked customers to post the notification letter on the affected equipment until retrofit was completed. Questions were to be directed to the GE Service Center at 800-766-6062.

Device

Device Recall Phoenix x/ray analyser series
  • 모델명 / 제조번호(시리얼번호)
    All affected units.
  • 의료기기 등급
    Not Classified
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Phoenix x/ray analyser series. || Phoenix x|ray analyser series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology.
  • Manufacturer
    GE Inspection Technologies, LP

Manufacturer

GE Inspection Technologies, LP
  • 제조사 주소
    GE Inspection Technologies, LP, 50 Industrial Park Rd, Lewistown PA 17044-9312
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA