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

  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : VA, NJ, MI, GA, and Internationally to France
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Spacelabs Healthcare Inc, 35301 SE Center St, Snoqualmie WA 98065-9216
  • Manufacturer Parent Company (2017)
  • Source
    USFDA