Events

Device Recall Supporter toilet armrest 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Etac Supply Center Ab 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
    71515
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2073-2015
  • 사례 시작날짜
    2015-06-15
  • 사례 출판 날짜
    2015-07-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138056
  • 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
    Adaptor, hygiene - Product Code ILS
  • 원인
    The supporter toilet armrest has two fast nuts fixing the product to the toilet porcelain. the firm has reports of the two fast nuts coming loose and causing the supporter to become unsteady.
  • 조치
    Etac sent an Urgent Notice of Field Correction beginning June 15, 2015, to all affected consignees. The letter directed the consignees to do an in field correction with replacement Fast Nuts. Defined replacement instructions were included with the replacement nuts. Customers with questions were instructed to contact their Etac distributor or the Etac coordinator, Snug Seal Inc. at 1-800-336-7683. For questions regarding this recall call 1-800-367-6844.

Device

Device Recall Supporter toilet armrest
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers higher than 224017
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including GA, CT and PA.
  • 제품 설명
    Etac Supporter toilet armrest || Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the hands. Supporter is simple to mount without the need for any tools. It fits both floor and wall mounted toilets. If space around the toilet is limited either armrest can easily be detached. Supporter includes seat ring and lid.
  • Manufacturer
    Etac Supply Center Ab

Manufacturer

Etac Supply Center Ab
  • 제조사 주소
    Etac Supply Center Ab, Langgatan 12, Anderstorp Sweden
  • 제조사 모회사 (2017)
    Nordstjernan Ab
  • Source
    USFDA