Events

Device Recall xcube and VTOMEX 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
    69846
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0426-2015
  • 사례 시작날짜
    2014-11-10
  • 사례 출판 날짜
    2014-12-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131689
  • 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, industrial - Product Code RCE
  • 원인
    Ge discovered these cabinet x-ray systems' potential failure to comply with the cabinet x-ray system performance standards.
  • 조치
    GE intends to notify its customers of the affected cabinet x-ray systems regarding the warning signs' potential failure to comply with 21 C.F.R. ¿ 1020.40(c)(7)(v) through a Technical Information Letter. The notification will inform customers that GE plans to replace the current warning signs with warning signs that comply with the requirements set forth in 21 C.F.R. ¿ 1020.40(c)(7)(v). GE will recommend in its notification that it replace the warning sign at the customer's next service interval, but no later than December 31, 2014. For further questions please call (717) 447-1278.

Device

Device Recall xcube and VTOMEX
  • 모델명 / 제조번호(시리얼번호)
    XXL cabinet x-ray systems, serial numbers A586590 and A586780; xlcube compact cabinet x-ray systems, serial numbers A583730, A586430, and A586460; a VTOMEX C450 cabinet x-ray system, serial number VTXO1JOOO2-2245 14; VTOMEX L300 cabinet x-ray systems, serial numbers VTX01lF007-208813, VTX01F007-196312 and VTXO1FOO07-1946 12; and VTOMEX L450 cabinet x-ray systems, serial numbers VTXO1K0001-184711 and PX_10E000-179013.
  • 의료기기 등급
    Not Classified
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of MI, PA, NH, CA, OR, WA, NC, IN and SC.
  • 제품 설명
    GE Cabinet X-ray systems
  • 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