Events

Etac Ono, Avant, and Salsa Walkers 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
    61463
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2014-2012
  • 사례 시작날짜
    2012-04-06
  • 사례 출판 날짜
    2012-07-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-06-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108163
  • 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
    Walker, mechanical - Product Code ITJ
  • 원인
    The recall has been initiated because there is the potential that users may fall and become injured, with the potential for serious injury, including bone fracture. one death occurred in a user fall incident, but it is unclear whether the fall was caused by the loss of a wheel. among the walkers distributed worldwide, etac¿ has received a total of 49 reports from europe and japan of wheels falling.
  • 조치
    Etac sent an "URGENT DEVICE RECALL " letter dated March 20, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately discontinue selling and distributing the affected product. A Reply Postcard was enclosed for customers to complete and return. Contact the firm at 847-277-7705 for questions regarding this recall.

Device

Etac Ono, Avant, and Salsa Walkers
  • 모델명 / 제조번호(시리얼번호)
    Model numbers: 15030102-15, 15030103-15 , 15030202-15, 15030403-15 , 15031003-14, 15040105-14, 15040105-33, 15040301-14, 15040301-33, and 15110101-18.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, China, Colombia, Germany, Denmark, Estonia, Spain, Finland, France, Great Brittain, Greenland, Greece, Hungaria, Ireland, Israel, Iceland, Italy, Japan, South Korea, Kuwait, Lithuania, Luxembourg, Latvia, Malaysia, Netherlands, Norway, Poland, Portugal, Rumania, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, and Thailand.
  • 제품 설명
    Etac¿ Ono Walker, Etac¿ Avant Walker, and Etac¿ Salsa Walker. || These products are four-wheeled walkers intended as a walking aid for indoor and outdoor use for persons weighing up to 125 KG.
  • 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