Events

Device Recall GE Automatic Mobile XRay Systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare, LLC 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
    61553
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1399-2012
  • 사례 시작날짜
    2011-12-23
  • 사례 출판 날짜
    2012-04-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108410
  • 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
    Ge healthcare has become aware of a discrepancy on the x-ray source assembly of the mobile radiographic product, related to the light field to x-ray field edge alignment.
  • 조치
    GE Healthcare will issue an Important Electronic Product Radiation Warning letter to customers. The letter will describe the defect and related hazards, along with the safety instructions, affected product, and product correction GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal and IEC standard in accordance with an approved plan, the details of which will be included in a subsequent communication to customers or through a GE Healthcare field engineer site visit. A GE Healthcare Service Representative will update the external tube port on the source assembly to address the issue. Questions or concerns can be directed to the Call Center at 800-437-1171 or your local GE Healthcare Service Representative.

Device

Device Recall GE Automatic Mobile XRay Systems
  • 모델명 / 제조번호(시리얼번호)
    All associated serial numbers.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA (nationwide)
  • 제품 설명
    GE Healthcare Automatic Mobile X- Ray (AMX) series: Brivo XR285 15KW, Brivo XR285 30KW, Optima XR200 15KW, Optima XR200 30KW, Optima XR220 15KW, and Optima XR220 30KW. || General Electric, Waukesha, WI || Indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • 제조사 주소
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA