SlingBar 670 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hill-Rom, 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
    64550
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1475-2013
  • 사례 시작날짜
    2013-04-30
  • 사례 출판 날짜
    2013-06-05
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-11-28
  • 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
    Lift, patient, non-ac-powered - Product Code FSA
  • 원인
    Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a simulated test method. in effort to eliminate any risk of injury, hill-rom is requesting products be removed from field use and replaced with an updated design.
  • 조치
    On 4/30/13 an URGENT MEDICAL DEVICE RECALL CORRECTION was issued to all consignees detailing the hazards and actions that are needed. Included with this notification is a Response Form/Receipt and a Replacement Guide, complete and return the form to Hill-Rom as soon as possible. Hill-Rom will send you the applicable number of sling bars to you at no cost. After you receive the new sling bars, we request that you discard the old ones.

Device

  • 모델명 / 제조번호(시리얼번호)
    Product # 3156012, 3156017
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, IL, IN, KS, LA, MA, MI, MN, MO, NC, NH, NJ, NV, OH, OK, PA, SC, TN, UT, WA, and WI, and the countries of Canada, Australia, Austria, Belgium, Switzerland, Germany Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Norway, New Zealand, Portugal, Sweden, and Turkey.
  • 제품 설명
    SlingBar Wide 670. || Designed to meet the needs for lifting humans.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Hill-Rom, Inc., 1069 State Route 46 East, Batesville IN 47006-7520
  • 제조사 모회사 (2017)
  • Source
    USFDA