Events

Device Recall GE Healthcare/Ohmeda Medical Giraffe OmniBed. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Datex Ohmeda, Inc. dba GE Healthcare 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
    49097
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0305-2009
  • 사례 시작날짜
    2008-06-20
  • 사례 출판 날짜
    2008-11-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-03-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72753
  • 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
    Neonatal lncubator. - Product Code FMZ
  • 원인
    Manufacturer of neonatal incubators changed the device labeling to account for new use and care instructions.
  • 조치
    A notification letter (Urgent Medical Device Correction) was sent to consignees on 06/20/08. The notification letter addressed healthcare professionals, including neonatal, infection control and nursing departments at medical facilities. In add tion, the letter advised of revisions to the current Giraffe OmniBed¿¿ cleaning instructions contained in the product Operators Manual. Instructions were enclosed with the notification letter and are intended to supplement those already present in the manual. Contact the GE Healthcare Technical Support center at 1-800-558-7044 for questions or additional information. If outside of the USA, please contact your local GE Healthcare Service Representative.

Device

Device Recall GE Healthcare/Ohmeda Medical Giraffe OmniBed.
  • 모델명 / 제조번호(시리얼번호)
    All lots.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: The devices were widely distributed to national and international medical facilities.
  • 제품 설명
    Giraffe OmniBed¿, labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. || The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand.
  • Manufacturer
    Datex Ohmeda, Inc. dba GE Healthcare

Manufacturer

Datex Ohmeda, Inc. dba GE Healthcare
  • 제조사 주소
    Datex Ohmeda, Inc. dba GE Healthcare, 8880 Gorman Rd, Laurel MD 20723-5800
  • Source
    USFDA