Events

Ohmeda Giraffe¿ SPOT PT Lite¿ Phototherapy System 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
    32920
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0160-06
  • 사례 시작날짜
    2005-08-05
  • 사례 출판 날짜
    2005-11-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-10-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41078
  • 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
    Unit, Neonatal Phototherapy - Product Code LBI
  • 원인
    Phototherapy medical device may lose its position and can cause a safety hazard to the patient.
  • 조치
    The firm notified consignees by letter on 08/05/2005 and advised of field correction of the devices in 2 phases. The letter is lot specific and provides for an interim workaround and includes an adhesive sticker and instructions for tagging the device with a warning statement containing restriction for use : 'This phototherapy light should ONLY be used on patients in closed incubators.' The letter further advises of firm''s plan to provide free, mandatory repair at a later date, pending hardware solution.

Device

Ohmeda Giraffe¿ SPOT PT Lite¿ Phototherapy System
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: HEBE50008 - HEBE50019;  HEBF50001 - HEBF50311;  HEBG50001 - HEBG50751;  HEBH50001 - HEBH50950;  HEBJ50000 - HEBJ50432;  HEBG54001 - HEBG54035;  HEBH54001 - HEBH54999; HEBH55000 - HEBH55041;  HEBJ55033 - HEBJ55036;
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distributed to medical facilities in the US and international subsidiaries and distributors.
  • 제품 설명
    Ohmeda Giraffe¿ SPOT PT Lite¿ Phototherapy System
  • 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