Events

Device Recall Regional Oximetry Sensor 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
    70045
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0901-2015
  • 사례 시작날짜
    2014-11-25
  • 사례 출판 날짜
    2014-12-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-09-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132186
  • 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
    Oximeter - Product Code DQA
  • 원인
    Nonin medical is conducting a recall of certain regional oximetry sensors and associated products. they have received reports of signal loss during use of our shortcabled regional oximetry sensors with diaphoretic patients. no injury or illness have been reported.
  • 조치
    Consignees were sent a Nonin letter dated November 24, 2014. The letter described the problem and the product affected. They requested consignees to discontinue the use of the products and return it to Nonin. Consignees were asked to complete and return the "Medical Device Market Withdrawal Return Response Form". For questions and additional information they can contact James H. Russell at 763-577-2260 or e-mail jim.russell@nonin.com.

Device

Device Recall Regional Oximetry Sensor
  • 모델명 / 제조번호(시리얼번호)
    PRTNUM_72 PMDES1_01 LOTNUM_72 8825001 PKG ASSY, INT100 25605 8825001 PKG ASSY, INT100 414312 8825001 PKG ASSY, INT100 414353 8825001 PKG ASSY, INT100 414405 8825001 PKG ASSY, INT100 418061 9705001 PKG ASSY, 8004CA, 20PK 37245 9705001 PKG ASSY, 8004CA, 20PK 36349 9705001 PKG ASSY, 8004CA, 20PK 36475 9705001 PKG ASSY, 8004CA, 20PK 36476 9705001 PKG ASSY, 8004CA, 20PK 36477 9705001 PKG ASSY, 8004CA, 20PK 36593 9705001 PKG ASSY, 8004CA, 20PK 36693 9705001 PKG ASSY, 8004CA, 20PK 36694 9705001 PKG ASSY, 8004CA, 20PK 36695 9705001 PKG ASSY, 8004CA, 20PK 36696 9705001 PKG ASSY, 8004CA, 20PK 36697 9705001 PKG ASSY, 8004CA, 20PK 36698 9705001 PKG ASSY, 8004CA, 20PK 36886 9705001 PKG ASSY, 8004CA, 20PK 36887 9705001 PKG ASSY, 8004CA, 20PK 36989 9705001 PKG ASSY, 8004CA, 20PK 37066 9705001 PKG ASSY, 8004CA, 20PK 37094 9705001 PKG ASSY, 8004CA, 20PK 37151 9705001 PKG ASSY, 8004CA, 20PK 37245 9705001 PKG ASSY, 8004CA, 20PK 37374 9705001 PKG ASSY, 8004CA, 20PK 37410 9705001 PKG ASSY, 8004CA, 20PK 37514 9705001 PKG ASSY, 8004CA, 20PK 37515 9705001 PKG ASSY, 8004CA, 20PK 37591 9705001 PKG ASSY, 8004CA, 20PK 37607 9705001 PKG ASSY, 8004CA, 20PK 37669 9705001 PKG ASSY, 8004CA, 20PK 37670 9824001 PKG ASSY, 8003CA, 20 PK 36611 9824001 PKG ASSY, 8003CA, 20 PK 36888 9824001 PKG ASSY, 8003CA, 20 PK 36937 9824001 PKG ASSY, 8003CA, 20 PK 37090 9824001 PKG ASSY, 8003CA, 20 PK 37231 9824001 PKG ASSY, 8003CA, 20 PK 37575
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    To be provided later.
  • 제품 설명
    SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Wavelength), 8004CA (REF 9705-001, 4-Wavelength), with associated materials (INT-100 cable, operator's manual; and Quick Start Guide). || Sensors are single-packed in a pouch, then multi-packed, 20 per shelf-box.
  • Manufacturer
    Nonin Medical, Inc

Manufacturer

Nonin Medical, Inc
  • 제조사 주소
    Nonin Medical, Inc, 13700 1st Ave N, Plymouth MN 55441-4595
  • 제조사 모회사 (2017)
    Nonin Medical, Inc.
  • Source
    USFDA