Events

SONNET 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 MED-EL Elektromedizinische Gereate, Gmbh 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
    76503
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1395-2017
  • 사례 시작날짜
    2016-10-25
  • 사례 출판 날짜
    2017-03-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153386
  • 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
    Pylon, post surgical - Product Code ISM
  • 원인
    Unit defect: firm inspection revealed units did not have the compartment lock firmly welded to the housing.
  • 조치
    MED-EL is notifying all consignees to whom affected products have been directly shipped by Headquarters (based on first delivery shipment records) on 10/25/2016.

Device

SONNET
  • 모델명 / 제조번호(시리얼번호)
    Part No. 32291, Kit 33372, Kit UDI - Primary ID: 09008737333720 (anthracite 50); Part No. 32292, Kit 33374, Kit UDI - Primary ID: 09008737333744 (ebony 50); Part No. 32293, Kit 33375, Kit UDI - Primary ID: 09008737333751 (black 50); Part No. 32294, Kit 33376, Kit UDI - Primary ID: 09008737333768 (white 50); Part No. 32295, Kit 33377, Kit UDI - Primary ID: 09008737333775 (beige 50) and Part No. 32296, Kit 33378, Kit UDI - Primary ID: 09008737333782 (grey 50).
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of CA, NC and TX; and the countries of Belgium, Belarus, Canada, France, Germany, Hong Kong, Israel, Netherlands, Philippines, Poland, Portugal, Turkey, United Kingdom, and Uruguay.
  • 제품 설명
    SONNET Mini Battery Pack CableProduct Usage: || The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini Battery Pack Cable lengths to connect the SONNET Mini Battery Pack to one processor unit.
  • Manufacturer
    MED-EL Elektromedizinische Gereate, Gmbh

Manufacturer

MED-EL Elektromedizinische Gereate, Gmbh