Device Recall Power Bariatric Recliner 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
    73138
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0860-2016
  • 사례 시작날짜
    2016-01-20
  • 사례 출판 날짜
    2016-02-23
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-02-07
  • 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
    Chair, geriatric - Product Code FRJ
  • 원인
    The recliners were shipped without the foot rest ottoman linkage side shields, which could result in consumer injury.
  • 조치
    Hill-Rom sent an Urgent Field Safety Notice by POD (Proof of Delivery) mailing on January 20, 2016, to all affected customers.. The notice identified the product, the problem, and the action to be taken by the customer. Customers willl be contacted for appointments to update the power chairs with missing linkage side shields. Hill-Rom will be installing the missing linkage side shields to the Hill-Rom P9096 Power Bariatric Recliner to address this issue. Customers were instructed to ensure patients and others do not insert an appendage into the foot rest linkage mechanism during opening or closing. Customers may contact Hill-Rom Technical Support at 800-445-3720, if they have any questions.

Device

  • 모델명 / 제조번호(시리얼번호)
    Bariatric Power Recliner, Product Model # P9096; all power bariatric chairs that are affected by this field action is distributed within the following serial number range:  L341RW9151 through P070RW0812
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, VT, WA, WI, WV, WY, VA Medical Center and Internationally to Canada and Mexico. **Consumer Recommended Depth - Consumers/User**
  • 제품 설명
    Hill-Rom Bariatric Power Recliner, Product Model # P9096 || Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience for the bariatric patient. Using spring box construction and an exceptionally smooth mechanism, the patient is able to move into a reclined position with little effort and infinite positions up to 38 degrees. An independent footrest enables patients to be in a fully seated position with their feet up for added comfort.
  • Manufacturer

Manufacturer

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