Events

Device Recall CLINITRON UPLIFT 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hill-Rom Manufacturing, 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
    52524
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1903-2009
  • 사례 시작날짜
    2009-06-24
  • 사례 출판 날짜
    2009-08-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83192
  • 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
    Bed, air fluidized - Product Code INX
  • 원인
    Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed.
  • 조치
    Hill-Rom issued an "Urgent Field Safety Notice" letter dated February 2, 2009 addressed to Facility Risk Managers and Facility Administrators. The notice detailed the issue and instructed users on actions to be taken. For further information, please contact Hill-Rom Customer Service at 1-800-638-2546.

Device

Device Recall CLINITRON UPLIFT
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States, Abu Dhabi, Brazil, Canada, Chile, Columbia, Mexico, Newfoundland, Puerto Rico, Saudi Arabia, Singapore, Taiwan, Turkey and Venezuela.
  • 제품 설명
    CLINITRON¿ UP-LIFT" Air Fluidized Therapy Units. || Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problems and who generally also have one or more of the following conditions: immobility, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue or multi-system failure.
  • Manufacturer
    Hill-Rom Manufacturing, Inc.

Manufacturer

Hill-Rom Manufacturing, Inc.
  • 제조사 주소
    Hill-Rom Manufacturing, Inc., 4349 Corporate Rd, Charleston SC 29405-7445
  • Source
    USFDA