Events

NicoletOne Software v5.94 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Natus Neurology 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
    71991
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0117-2016
  • 사례 시작날짜
    2015-09-11
  • 사례 출판 날짜
    2015-10-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-03-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139574
  • 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
    Full-montage Standard Electroencephalograph - Product Code GWQ
  • 원인
    When using the nicoletone v5.94 software, after exiting the impedance check function and returning to the eeg screen, the impedance check signal remains active in waveform, obscuring the eeg signals.
  • 조치
    Natus Neurology sent an Ugent Medical Device Corrrection Notification letter dated September 9, 2015 to all affected consignees. The letter described the problem and the product involved in the recall. Consignees were informed consignees that a Field Service Technician will contact them to install the new software. Once the software is installed they will ask the Recipient or Field service Technician to complete and return the Verification Form. For questions regarding this recall call 608-829-8600.

Device

NicoletOne Software v5.94
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers include TS150456M, TR150171M, TR150172M, 1TR150173M, TR150174M, TS150451M, TS150452M, TR150170M, UH150119M, TR150169M, UR150226M, UR150227M, UR150228M, UR150229M, TS150455M, TS150457M, TS150458M, TS150454M, TS150453M, UC150184M, PN151700M, SJ150272M, TT150134M, PN151699M, UR150230M, UR150231M, and SJ150271M.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. US nationwide, INDIA, ROMANIA, DENMARK, JAPAN, AUSTRALIA, RUSSIA, BANGLADESH, SRI LANKA, BRUNEI, and UNITED ARAB EMIRATES.
  • 제품 설명
    NicoletOne Software v5.94, Catalog/Part Number: 482-649600. || The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, measure, store and display full band (FbEEG) cerebral EEG and extracerebral activity for Clinical EEG, Electrocorticography (EcOG), Long Term Monitoring (LTM), Intensive Care Unit (ICU) monitoring and Polysomnography (PSG) Sleep studies. While the Nicolet Neurodiagnostic systems are capable of displaying signals, such as Sp02 and EKG, the system is NOT intended for monitoring such signals for the preservation of life, The Nicolet Neurodiagnostic systems are intended to acquire, analyze, and display data
  • Manufacturer
    Natus Neurology Inc

Manufacturer

Natus Neurology Inc
  • 제조사 주소
    Natus Neurology Inc, 3150 Pleasant View Rd, Middleton WI 53562-4800
  • 제조사 모회사 (2017)
    Natus Medical Incorporated
  • Source
    USFDA