Events

SmartEP 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Intelligent Hearing Systems Corp. 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
    54168
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1704-2010
  • 사례 시작날짜
    2008-10-21
  • 사례 출판 날짜
    2010-05-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-09-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87751
  • 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
    neurological hearing tester - Product Code GWJ
  • 원인
    This was a marketing correction mandated by the united states food and drug administration (usfda). usfda notified intelligent hearing systems that 501(k) premarket notification application must be submitted and cleared in order to market and sell devices with vestibular evoked myogenic potential (vemp) specific functions. the food and drug administration considers that the vemp testing functions.
  • 조치
    Intelligent Hearing Systems sent a letter "Information Regarding the Discontinued Use of the SmartEP Evoked Response System for Vestibular Evoked Myogenic Potentials (VEMP) Testing" dated September 30, 2008 to customers and distributors. Each customer will receive an upgrade and VEMP removal kit which will remove the VEMP feature.

Device

SmartEP
  • 모델명 / 제조번호(시리얼번호)
    IHS2195, IHS3048V, IHS3116, IHS3128V, IHS3182, IHS3420, IHS3431, IHS3443, IHS3485, IHS3545, IHS3563, IHS3565, IHS3580, IHS3591, IHS3642, IHS3665, IHS3668, IHS3683, IHS3829, IHS3878, IHS3967, IHS4001, IHS2209, IHS2281, IHS3110, IHS3324, IHS3410, IHS3426, IHS3460, IHS3542, IHS3548, IHS3623, IHS3638, IHS3787, IHS3961, IHS3011, IHS3387, IHS3429, IHS3432, IHS3494, IHS3593, IHS3619, IHS3704, IHS2184, IHS3008, IHS3248, IHS3314, IHS3819, IHS3893, IHS4040.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution.
  • 제품 설명
    Intelligent Hearing Systems Corporation, SmartEP with Vestibular Evoked Myogenic Potentials Version 3.96. Model M811016
  • Manufacturer
    Intelligent Hearing Systems Corp.

Manufacturer

Intelligent Hearing Systems Corp.