Device Recall Fitness Gear Inversion table 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Dick's Sporting Goods 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
    70136
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1003-2015
  • 사례 시작날짜
    2014-12-29
  • 사례 출판 날짜
    2015-01-20
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-09-02
  • 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
    Apparatus, traction, non-powered - Product Code HST
  • 원인
    Reports of customers falling from the inversion table and sustaining injuries. the inversion table is a fitness product, not a medical device. dsg removed medical claims from product labels and advertising.
  • 조치
    DSG sent emails and medical device correction notices, dated December 2014, to consumers who made purchases online and retail store consumers for whom DSG has contact information via its Scorecard customer loyalty program. DSG also posted the recall on their web site and notified their retail stores with instructions to post notices in DICKs stores. DSG plans to remind stores approximately monthly for three months to display the recall poster, beginning one month after the recall announcement. Consumers were asked to return the product to the stores where they were purchased for a full refund. A Press Release, dated January 8, 2015, was also issued about the recall.

Device

  • 모델명 / 제조번호(시리얼번호)
    Style STE00059FG and Style STE00118FG
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide.
  • 제품 설명
    Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distributed by ASLI, Wilmington, DE (on carton), Paradigm Health & Wellness, Inc. (in user manuals); The products are inversion tables, which allow the user to secure his or her ankles to the table and invert. The products were intended to be fitness equipment; i.e. consumer products.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Dick's Sporting Goods, 345 Court St, Coraopolis PA 15108-3817
  • 제조사 모회사 (2017)
  • Source
    USFDA