Events

Device Recall Handy Laser Compact Laser centering 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
    69849
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2320-2015
  • 사례 시작날짜
    2014-11-10
  • 사례 출판 날짜
    2015-08-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-02-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131702
  • 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, tomography, computed - Product Code RER
  • 원인
    Ge has identified a potential failure to comply with 21 c.F.R. ¿ 1040.10 and 21 c.F.R. ¿ 1010.2 for the alignment laser centering device.
  • 조치
    GE's Planned Action for repair: 1. Replacement compliant laser centering devices will be shipped to purchasers, with prepaid shipping envelopes for purchasers to return the noncompliant units to GE. 2.All mailings will be made at no cost to the purchaser; and 3.The corrections will be completed by November 1, 2015 Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator are to be included in the notification. For further questions please call (717) 447-1278.

Device

Device Recall Handy Laser Compact Laser centering
  • 모델명 / 제조번호(시리얼번호)
    Model No. 025.03.00A
  • 의료기기 등급
    Not Classified
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : NY, CA, WA, PA, MD, AL, FL and LA.
  • 제품 설명
    GE Optional Laser Centering Device X-ray generator.
  • 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