Events

Device Recall Cybernet Medical MedStar Telemedicine System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cybernet Systems Corp. 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
    53785
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0854-2010
  • 사례 시작날짜
    2008-01-23
  • 사례 출판 날짜
    2010-02-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-10-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86513
  • 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
    Transmitters and receivers, electrocardiograph, telephone - Product Code DXH
  • 원인
    A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.
  • 조치
    The firm sent out a recall letter dated 10/27/09. Consignees were asked to return the devices in prepaid shipping containers. The recalling firm would do a software upgrade and return the device to the consignee. The firm expects it to take 3-6 months to upgrade all devices. Contact Cybernet Medically immediately, at 1-800-CYBERNET, with the serial number and code versions of the devices in question and Cybernet will start the RMA process for returning the devices for the updates, free of cost.

Device

Device Recall Cybernet Medical MedStar Telemedicine System
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 3812, 3814 and 3824 have not yet been corrected. No others were in need of correction.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: California, Florida, Georgia, Illinois, Louisiana, Michigan, Mississippi, New York, Oklahoma and West Virginia.
  • 제품 설명
    Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann Arbor, MI; Model 533-386. || The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line.
  • Manufacturer
    Cybernet Systems Corp.

Manufacturer

Cybernet Systems Corp.
  • 제조사 주소
    Cybernet Systems Corp., 727 Airport Blvd, Ann Arbor MI 48108-1639
  • 제조사 모회사 (2017)
    Cybernet Systems
  • Source
    USFDA