Events

Ohmeda Medical''s Giraffe¿ OmniBeds¿ and Giraffe Incubators 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ohmeda Medical, A division of Datex-Ohmeda, 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
    31665
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1047-05
  • 사례 시작날짜
    2005-04-25
  • 사례 출판 날짜
    2005-07-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-01-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38318
  • 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
    Incubator, Neonatal - Product Code FMZ
  • 원인
    Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply.
  • 조치
    Ohmeda Medical notified consignees 04/25/05 by letter flagged as an 'Urgent Medical Device Correction'. The serial number specific notification advised that the elevating base may move following the mains power interruption. The letter further advised that the notice should not be confused with a previous (medical device correction) letter sent concerning movement of the elevating base caused by the footswitches on the device. Ohmeda indicated in the letter that users may continue to use the device with stated precautions, pending hardware upgrade by the firm''s service technologists.

Device

Ohmeda Medical''s Giraffe¿ OmniBeds¿ and Giraffe Incubators
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: HDHE50001 to HDHE50164; HDHF50001 to HDHF50357; HDHF52001 to HDHF52212; HDHF53001 to HDHF53156; HDHF54001 to HDHF54168; HDHG54001 to HDHG54320; HDGD50200 to HDGD50389; HDGE50001 to HDGE50591; HDGF50001 to HDGF50046; HDGF52001 to HDGF52036; HDGF53001 to HDGF53102; HDGF54001 to HDGF54190; HDGG54001 to HDGG54367
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The incubators were distributed to hospital neonatal intensive care centers across the US. The devices were additionally distributed to international subsidiaries and distributors.
  • 제품 설명
    Ohmeda Medical''s Giraffe¿ OmniBeds¿ and Giraffe Incubators
  • Manufacturer
    Ohmeda Medical, A division of Datex-Ohmeda, Inc.

Manufacturer

Ohmeda Medical, A division of Datex-Ohmeda, Inc.
  • 제조사 주소
    Ohmeda Medical, A division of Datex-Ohmeda, Inc., 8880 Gorman Rd, Laurel MD 20723-5800
  • Source
    USFDA