Events

Device Recall Etac Relax 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
    71707
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2381-2015
  • 사례 시작날짜
    2015-07-12
  • 사례 출판 날짜
    2015-08-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-02-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138795
  • 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 recalling firm has received reports of a malfunction of the relax wall mounted shower seat where the wall bracket has cracked or broken.
  • 조치
    Etac sent an Urgent Field Safety Notice dated July 2015 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that there was no reason for an immediate stop of using Relax, however, as an intermediate precautionary action awaiting replacement, consumers were requested to be observant and inspect the Relax to see if there are visible signs of a crack. Customers with questions were advised to contact their Etac distributor or the Etac coordinator at 1-800-336-7684 or fax 1-704-882-0751.

Device

Device Recall Etac Relax
  • 모델명 / 제조번호(시리얼번호)
    The affected products are individually identified within the serial number range: 1-425 regarding Art No. 81703030, 1-205 regarding Art No. 81703050, All distributed regarding Art No. 81703080
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including FL, AZ, and CA.
  • 제품 설명
    Etac Relax wall mounted shower seat || The Etac Relax is a wall mounted shower seat designed as a seating and standing support for personal hygiene purposes for people with reduced mobility. The Etac Relax shower seat is used for sitting where space is restricted, and can be folded up when not in use. Etac Relax is intended for home use.
  • 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