Device Recall RotoRest Delta Kinetic Therapy System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 KCI USA, 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
    62805
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0409-2013
  • 사례 시작날짜
    2012-06-27
  • 사례 출판 날짜
    2012-11-20
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-04-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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, flotation therapy, powered - Product Code IOQ
  • 원인
    The firm is initiating a voluntary medical device correction for the rotorest delta therapy system head pack. kci has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack. in a few instances, the patient received injuries ranging from stage iii to stage iv pressure ulcers.
  • 조치
    KCI sent an Urgent - Voluntary Medical Device Correction letter dated June 27, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that KCI would contact them soon to coorinate a shipment of a replacement of the affected product. For any questions customers were instructed to call 1-800-275-4524, Selection Option 3 followed by Option 2. For questions regarding this recall call 1-800-275-4524.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Number 208030, Serial Numbers: 00157087, 00157091, 00157288, 00157375, 00157405, RRCKOO011, RRHKOO065, RRHKOO074, RRHKOO096, RRHK00109, and RRHKOO117.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including AL, CA, CO, OK and GA.
  • 제품 설명
    RotoRest Delta Kinetic Therapy System || INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction
  • Manufacturer

Manufacturer

  • 제조사 주소
    KCI USA, Inc., 4958 Stout Dr, San Antonio TX 78219-4334
  • Source
    USFDA