Events

Device Recall Norco Shoulder Pulley 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 North Coast 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
    61475
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1542-2012
  • 사례 시작날짜
    2011-07-11
  • 사례 출판 날짜
    2012-05-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108183
  • 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
    Exerciser, non-measuring - Product Code ION
  • 원인
    Potential for plastic d-ring to break during use and cause injury.
  • 조치
    North Coast Medical began contacting customers of the recall on July 13, 2011 by telephone. A phone script was used to inform customers of the affected product, problem, and actions to be taken by the customers. Information was provided for customers to return affected product. Affected devices were re-worked and inspected. Contact the firm by e-mail at www.ncmedical.com for questions regarding this recall.

Device

Device Recall Norco Shoulder Pulley
  • 모델명 / 제조번호(시리얼번호)
    Product number NC52069. Product does not have lot/serial numbers, expiration dates or UPC numbers.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Switzerland, Germany, Great Britain and the Netherlands.
  • 제품 설명
    Norco Shoulder Pulley || Distributed by North Coast Medical, Gilroy, CA. || Used to improve range of shoulder movement and coordination following a stroke, shoulder injury or surgery.
  • Manufacturer
    North Coast Medical Inc

Manufacturer

North Coast Medical Inc
  • 제조사 주소
    North Coast Medical Inc, 8100 Camino Arroyo, Gilroy CA 95020-7304
  • 제조사 모회사 (2017)
    North Coast Medical Inc.
  • Source
    USFDA