Events

Transport Chair and Rollator in 1 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Silver Star Brands 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
    69487
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0216-2015
  • 사례 시작날짜
    2014-10-10
  • 사례 출판 날짜
    2014-11-14
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130754
  • 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
    Wheelchair, mechanical - Product Code IOR
  • 원인
    Silver star brands is recalling the transport chair and rollator in one because they have received several reports of the wheel assembly failing resulting in damaged wheels.
  • 조치
    Consignees were sent on 10/10/2014 an Easy Comforts "Urgent: Rollator Recall" letter dated October 10, 2014. The letter described the problem and the product involved in the recall. Advised consignees to stop using the product immediately. The consignees can contact the Product specialist at Easy Comforts at 1-888-327-2390 Monday though Friday from 7:30 am to 3:30 pm central time.

Device

Transport Chair and Rollator in 1
  • 모델명 / 제조번호(시리얼번호)
    SKU 348709 404, SKU348709 605
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including the states of AL, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, IA, KS, LA, MD, MI, MO, MT, NE, NV,NH, NM, NY, NC, OH,OK, and PA.
  • 제품 설명
    Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. || This is a walker/rolling chair. Used to assist injured and infirm people to walk or be ambulatory.
  • Manufacturer
    Silver Star Brands

Manufacturer

Silver Star Brands
  • 제조사 주소
    Silver Star Brands, 2155 S Oakwood Rd, Oshkosh WI 54904-6359
  • Source
    USFDA