Reported Jul 25, 2012 · Terminated
Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with…
Spacelabs Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spacelabs Healthcare, Llc · 5150 220th Ave Se · Issaquah, WA · 98029-6834
Is this the product you have?
- Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms. The Spacelabs Healthcare Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other devices via Flexport interfaces. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Spacelabs Healthcare Xprezzon Bedside Monitor may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitor allows network based applications to open windows and display information the Xprezzon and other networked monitors. The Spacelabs Healthcare Xprezzon Bedside Monitor is designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Xprezzon Bedside Monitors is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.
- Lot codes and dates
040-1632-001393-0000131393-0000391393-0000401393-0000411393-0003411393-0003821393-0003831393-0003841393-0003851393-0003861393-0003871393-0003881393-0008081393-0008311393-0013741393-0013751393-0014531393-0019901393-001991and 1393-001992
- Amount recalled
- 21 units
Where it was sold
Why it was recalled
There were reports that a certain combination of key presses will cause the module to disconnect from the Xprezzon bedside monitor, model 91393, and the patient parameters will drop from the display. The parameters return after power cycling the monitor.
This product could cause temporary or reversible health problems — stop using it.
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