Events

Servo Controlled Oxygen System for Ohmeda''s Medical Giraffe OmniBed and Ohmeda''s Medical Girraffe 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
    26719
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1064-03
  • 사례 시작날짜
    2003-06-13
  • 사례 출판 날짜
    2003-07-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2003-07-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28259
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
    unknown device name - Product Code 80FMZ
  • 원인
    Firm's received complaints of medical device malfunction affecting instrument's calibration and alarm systems.
  • 조치
    Recalling firm notified foreign distributors and domestic consignees by e-mail and phone on 6/13/2003. Foreign regional distributors were requested to manage the recall. The notification described various instrument problems and remedial action available via the firm''s field action retrofit kits, #6600-0126-850 for the Giraffe OmniBed and #6600-0261-850 for the Giraffe Incubator.

Device

Servo Controlled Oxygen System for Ohmeda''s Medical Giraffe OmniBed and Ohmeda''s Medical Girraf...
  • 모델명 / 제조번호(시리얼번호)
    Giraffe OmniBeds (w/Servo O2 option): HEDF50041 - HEDF50076 HDGE50562 ¿ HDGE50567, HDGF54039,  HDGF54153 ¿ HDGF54155 HDGF54165 ¿ HDGF54167  Giraffe Incubators (w/Servo O2 option):  HDHE50160-HDHE50161,  HDHF50023-HDHF50024, HDHF50105, HDHF50109, HDHF50114, HDHF50227- HDHF50245, HDHF50278, HDHF50302, HDHF50304, HDHF50306, HDHF50309, HDHF50327-HDHF50328, HDHF50333-HDHF50343, HDHF53070, HDHF54046, HDHF54122, HDHF54131-HDHF54133, HDHF54135, HDHF54143-HDHF54145, HDHF54152-HDHF54155.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Devices were sold to 15 international distributors and one domestic end user.
  • 제품 설명
    Servo Controlled Oxygen System for Ohmeda''s Medical Giraffe OmniBed and Ohmeda''s Medical Girraffe 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 Road, Laurel MD 20723
  • Source
    USFDA