Events

Device Recall Command Module 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Spacelabs Healthcare, Incorporated 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
    48759
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2342-2008
  • 사례 시작날짜
    2008-07-22
  • 사례 출판 날짜
    2008-09-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-07-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72067
  • 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
    Arrhythmia Detector and alarm - Product Code DSI
  • 원인
    Potential for module to fail to obtain a nibp reading on hypertension patients.
  • 조치
    On July 22, 2008 an "Urgent MEDICAL DEVICE CORRECTION" letter was mailed to all the firm's customers. The letter states the problem at hand, when the problem would likely to occur and instructions of a way to mitigate the risk, until the modules can be recalibrated . The firm's Customer Connectivity Center will confirm all affected customers have been notified. Spacelabs Technical Support will be recalibrating all modules personally and ensuring all corrections have been applied to all affected customers of record. Contact Spacelabs Healthcare at 1-800-522-7025 for assistance.

Device

Device Recall Command Module
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product is distributed nationwide and internationally to medical facilities.
  • 제품 설명
    Ultraview SL Command Module, Model 91496 || The product is intended for use with the Patient Care Monitoring System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include cardiac activity, respiration, invasive and noninvasive pressure, temperature, oxygen saturation (SpO2) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.
  • Manufacturer
    Spacelabs Healthcare, Incorporated

Manufacturer

Spacelabs Healthcare, Incorporated
  • 제조사 주소
    Spacelabs Healthcare, Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Source
    USFDA