Events

Device Recall AquaStar 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Micromedical Technologies, Inc 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
    53837
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0563-2010
  • 사례 시작날짜
    2009-11-16
  • 사례 출판 날짜
    2009-12-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-04-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86628
  • 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
    Water Caloric Irrigator - Product Code ETP
  • 원인
    Some of the filters on both the display board and the main electronic board (pcb) become oxidized causing the lcd display to be garbled and the timer will not operate.
  • 조치
    Micromedical Technologies, Inc. sent letters dated November 16, 2009 via e-mail (with read receipt) to each customer and their representative. If they did not have the customer's e-mail address, the sales representative was requested to forward the letter to the customer and copy Micromedical. The letters advised the customers that one or more electronic components in the AquaStar caloric irrigator may fail due to contact corrosion. In the event of this failure, unheated tap water will continue to flow through the device back to the water drain, but the LCD display will be garbled and the timer will not operate. If this problem develops, the account should stop using the irrigator and contact Micromedical Technologies, Inc. at 1-217-483-2122 or via e-mail at mmtinfo@micromedical.com to report the problem for repair of the unit.

Device

Device Recall AquaStar
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 1FX/17548/05,1GV/17548/01, 1GV/17548/02, 1GV/17548/03, 1GV/17548/04, 1GW/17549/01, 1GW/17549/02, 1GW/17549/07, 1GW/17549/08 and 1GW/17549/10.
  • 의료기기 분류등급
    Ear, Nose, and Throat Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States (New York and Pennsylvania), Canada, Egypt, Korea, Poland and South Africa.
  • 제품 설명
    AquaStar Water Caloric Irrigator; water caloric stimulator; Manufactured for/Distributed by Micromedical Technologies, Inc., 10 Kemp Drive, Chatham, IL 62629 USA, Instrumentation Difra, Made in Belgium. || The AquaStar water caloric irrigator delivers a precisely controlled temperature and flow rate of cool or warm water for vestibular stimulation during caloric testing. The caloric tests evaluate the viability of the horizontal semicircular canal by stimulating them with warm and cool water while the patient's eyes are closed. The resulting dizziness and nystagmus is taken as an index of the viability of the organ. The eyes are then opened to evaluate the ability of the CNS to visually suppress inappropriate dizziness and nystagmus.
  • Manufacturer
    Micromedical Technologies, Inc

Manufacturer

Micromedical Technologies, Inc