Events

Device Recall Spacelabs Medical Ultraview SL Command Module, Model 91496 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Spacelabs Healthcare, 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
    60764
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0776-2012
  • 사례 시작날짜
    2011-07-13
  • 사례 출판 날짜
    2012-01-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-01-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106417
  • 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
    Detector and alarm, arrhythmia - Product Code DSI
  • 원인
    One spacelabs medical ultraview sl command module, model 91496, was removed from customer due to software error.
  • 조치
    Spacelabs removed one affected unit of Medical Ultraview SL Command Module from a hospital in Troy, MI. during a site visit on July 13, 2011. This recall pertains to one single unit at one location. Contact Spacelabs at 425-657-7200 for questions regarding this recall.

Device

Device Recall Spacelabs Medical Ultraview SL Command Module, Model 91496
  • 모델명 / 제조번호(시리얼번호)
    Serial number: 1496-029792
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    One device distributed in Troy, MI.
  • 제품 설명
    Spacelabs Medical Ultraview SL Command Module, Model 91496. || The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management 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 ECG with arrhythmia detection, respiration, invasive and noninvasive blood 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, Llc

Manufacturer

Spacelabs Healthcare, Llc
  • 제조사 주소
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • 제조사 모회사 (2017)
    OSI Systems Inc
  • Source
    USFDA