Events

CARESTREAM DIRECTVIEW CR 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Carestream Health, 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
    69703
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0820-2015
  • 사례 시작날짜
    2014-10-30
  • 사례 출판 날짜
    2014-12-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131396
  • 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, image processing, radiological - Product Code LLZ
  • 원인
    Reduced mammographic image quality when attempting to print true size multi-format images.
  • 조치
    The firm, Carestream Health Inc., sent an "URGENT: Medical Device Recall" notice dated October 28, 2014 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to use the one-up printing option rather the multi-format printing option if a hard copy is required. Carestream has a software update that will address this issue. A Carestream service representative will contact all customers to schedule a visit to correct this software issue. If you have any questions or concerns or would like to request the installation of the previous software version that does not have this issue, please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis. Outside of the U.S. please call your local service support number.

Device

CARESTREAM DIRECTVIEW CR
  • 모델명 / 제조번호(시리얼번호)
    Software Verions: 1) 5.7.312.27 , 2) 5.7.312.27, 3) 5.7.312.2031
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US distribution to states of : NY, OH, and NC; and countries of: Argentina, Brazil, China, Chile, Colombia, France, Greece, Hong Kong, India, Japan, Korea, Mexico, Peru, Spain, Taiwan, and Thailand.
  • 제품 설명
    CARESTREAM DIRECTVIEW CR Software || Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
  • Manufacturer
    Carestream Health, Inc.

Manufacturer

Carestream Health, Inc.
  • 제조사 주소
    Carestream Health, Inc., 1049 W Ridge Rd, Rochester NY 14615-2731
  • 제조사 모회사 (2017)
    ONEX Corp
  • Source
    USFDA