FDA-Device2018-02-14Class II
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 demo
Spacelabs Healthcare Inc
Hazard
Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.
Sold states
US Distribution to the states of : VA, NJ, MI, GA, and Internationally to France
Affected count
12 systems
Manufactured in
35301 SE Center St, N/A, Snoqualmie, WA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0532-2018Don't want to check this manually?
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