Device Recall Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1

  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 6280-000359, 6280-000340, 6280-000336, 6280-000503, 6280-000502, 6280-000500, 6280-000496, 6280-000495, 6280-000327, 6280-000260, 6280-000566, 6280-000290
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : VA, NJ, MI, GA, and Internationally to France
  • 제품 설명
    Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) || The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient data of patients connected to Spacelabs Healthcare telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Spacelabs Healthcare Inc, 35301 SE Center St, Snoqualmie WA 98065-9216
  • 제조사 모회사 (2017)
  • Source
    USFDA