Events

Nonin Cerebral Oximeter Pod 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nonin 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
    53801
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0458-2010
  • 사례 시작날짜
    2009-10-23
  • 사례 출판 날짜
    2009-11-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86537
  • 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
    Tissue Saturation Oximeter - Product Code MUD
  • 원인
    A malfunction was detected with one of the components that, under rare circumstances, may result in the overheating of the pod. this overheating, while unlikely to occur, has the potential to cause a burn if the pod is in direct contact with the patient.
  • 조치
    An Urgent: Medical Device Recall letter was emailed to customers on 10/23/2009. The letter described the issue and hazard and asked that the use of the device be discontinued and to immediately contact Nonin for return and repair/replacement instructions. Questions or concerns should be directed to John Dalpee at 763-577-3166.

Device

Nonin Cerebral Oximeter Pod
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 500814470, 500814472, 500814474, 500814478, 500814480, 500814484, 500823139, 500823145, 500823146, 500823154, 500823159, 500823161, 500823164, 500823166, 500823172, 500823174, 500823175, 500823176, 500823181, 500823182, 500849316, 500849318, 500849321, 500849325, 500849331, 500849333, 500849336, 500849337, 500849338, 500849342, 500849343, 500849344, 500849347, 500849348, 500849349, 500849350, 500849351, 500849353, 500849356, 500849357, 500849358, 500849360, 500849361, 500849366, 500849367, 500849368, 500849369, 500849370, 500849372, 500849373, 500849375, 500849378, 500849380, 500849386, 500849387, 500849388, 500849389, 500849390, 500857060, 500857061, 500857064, and 500874926.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including states of LA, MN, NC, and NY and countries of Canada, Germany, Italy, Netherlands, and United Kingdom.
  • 제품 설명
    Nonin Model 7600B cerebral oximeter pod. Used with the Nonin Model 7600 Regional Oximeter with Equanox Technology and Bluetooth Wireless Technology. Nonin Medical, Inc., 13700 First Avenue North, Plymouth, Minnesota 55441-5443 USA.
  • Manufacturer
    Nonin Medical, Inc

Manufacturer

Nonin Medical, Inc
  • 제조사 주소
    Nonin Medical, Inc, 13700 1st Ave N, Plymouth MN 55441
  • 제조사 모회사 (2017)
    Nonin Medical, Inc.
  • Source
    USFDA