Events

Device Recall Renessa RF System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Novasys Medical 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
    53031
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1404-2010
  • 사례 시작날짜
    2009-07-27
  • 사례 출판 날짜
    2010-04-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-01-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84481
  • 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
    Applicator, transurethral, radio frequency, for stress urinary incontinence in women - Product Code NVJ
  • 원인
    Instructions for use (ifu) revision-- because of complaints received by the firm of worsened stress incontinence symptoms 3-4 weeks after treatment, the instructions for use were revised to emphasize potential side effects. although novasys has not, to date, identified a device malfunction associated with the symptoms discussed above, the investigation over time shows that there is a correlation.
  • 조치
    A Field Action notification letter was sent to all current customers (physicians) along with the revised instructions for use, and a small supply of the revised patient information brochures. The company also updated physician information brochures and patient/physician DVDs to include the information. This was shipped to physicians in August/September of 2009. Additional copies of the Patient Brochures can be ordered by contacting Novasys Customer Service at 866-784-4777. Questions should be addressed to the firm at the same telephone number.

Device

Device Recall Renessa RF System
  • 모델명 / 제조번호(시리얼번호)
    Issue affects all lots in distribution.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US nationwide only. (TX, FL, CA, LA, KY, MO, GA,OR WA, HI, AZ, OK AL, TN) .
  • 제품 설명
    Renessa RF System, model PR0918, manufactured by Novasys Medical, Newark, CA
  • Manufacturer
    Novasys Medical Inc

Manufacturer

Novasys Medical Inc
  • 제조사 주소
    Novasys Medical Inc, 39684 Eureka Dr, Newark CA 94560-4805
  • 제조사 모회사 (2017)
    Novasys Medical Inc
  • Source
    USFDA