Events

GE OEC Brivo 715 Prime 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE OEC 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
    69660
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0840-2015
  • 사례 시작날짜
    2014-09-15
  • 사례 출판 날짜
    2015-01-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-05-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131284
  • 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
    Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
  • 원인
    Ma accuracy may exceed the design and labeling specification of+ 10%. per 1020.32(f): deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with 1020.30(h)(3).
  • 조치
    Planned action(s) to repair defect or to bring product into compliance: GE Healthcare will, without charge, perform a mA calibration on all affected systems in the USA to bring the product back into compliance. The details of which will be included in a subsequent communication to customers or through a GE Healthcare field engineer site visit. Should customers have any questions or concerns regarding these corrections, please do not hesitate to contact the service team for further information at 800-874-7378 option 8.

Device

GE OEC Brivo 715 Prime
  • 모델명 / 제조번호(시리얼번호)
    GE OEC Brivo 715 Prime Serial Numbers:  B2S1301 6 B2S1301 8 B2S1302 1 B2S13022 B2S13025 B2S13039 B2S13060 B2S13063 B2S13065 B2S14001 B2S14007 B2S14022 B2S14039 B2S1404 0 B2S1404 5 B2S1406 5 B2S1406 6
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product || Used for general surgical applications and musculoskeletal procedures to visualize.
  • Manufacturer
    GE OEC Medical Systems, Inc

Manufacturer

GE OEC Medical Systems, Inc
  • 제조사 주소
    GE OEC Medical Systems, Inc, 384 N Wright Brothers Dr, Salt Lake City UT 84116-2862
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA