Events

Blackrock NeuroPort Biopotential Signal Processing System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Blackrock Microsystems, LLC 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
    74893
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2764-2016
  • 사례 시작날짜
    2016-08-10
  • 사례 출판 날짜
    2016-09-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-08-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148706
  • 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
    Amplifier, physiological signal - Product Code GWL
  • 원인
    Blackrock microsystems, llc announces a voluntary field action for the blackrock neuroport biopotential signal processing system because the neural signal amplifier and the patient cable are incorrectly labeled as type cf applied parts.
  • 조치
    Blackrock Microsystems sent an Urgent Medical Device letter dated August 12, 2016 via email. The letter identified the affected product, problem and actions to be taken. Customers were instructed not use the amplifier in application requiring a type CF applied part; perform a physical count of the inventory of amplifiers and patient cables with the part numbers listed. For questions regarding this Correction call 801-582- 5533, ext. 240.

Device

Blackrock NeuroPort Biopotential Signal Processing System
  • 모델명 / 제조번호(시리얼번호)
    Part Number 4460: All Serial Numbers Part Number 6735: All Serial Numbers
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and Canada,
  • 제품 설명
    Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons. || Product Usage: || The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP)
  • Manufacturer
    Blackrock Microsystems, LLC

Manufacturer

Blackrock Microsystems, LLC
  • 제조사 주소
    Blackrock Microsystems, LLC, 630 S Komas Dr, Ste 200, Salt Lake City UT 84108-1247
  • 제조사 모회사 (2017)
    Blackrock Microsystems Llc
  • Source
    USFDA