Events

Device Recall Medline EndurO2 Oxygen Concentrator without Oxygen Monitor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medline Industries 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
    47225
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1474-2008
  • 사례 시작날짜
    2008-03-04
  • 사례 출판 날짜
    2008-07-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-06-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69064
  • 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
    Portable Oxygen Generator - Product Code CAW
  • 원인
    Overheating of components: there is the potential for an electrical component in the oxygen concentrator to overheat, causing damage to the unit and making it nonfunctional.
  • 조치
    Consignees were notified by a letter sent on 3/4/08. The letter informed users that the recalling firm will replace the affected units with new units or issue a credit for the returned recalled units. Distributors were requested to notify their accounts of the recall. The letter requested users to complete and return an enclosed response sheet, indicating the number of units to be replaced or returned for credit. For additional information, contact 866-359-1704.

Device

Device Recall Medline EndurO2 Oxygen Concentrator without Oxygen Monitor
  • 모델명 / 제조번호(시리얼번호)
    Reorder Number: HCS021; All units produced since July 2006.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Medline EndurO2 Oxygen Concentrator without Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS021; Packaged in 1 unit per case; Product is an oxygen generator designed to provide oxygen to patient who has been prescribed oxygen therapy by a physician.
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • 제조사 주소
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4486
  • Source
    USFDA