Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

Spacelabs Healthcare qube Bedside Monitors, Model 91390, are recalled because the firm has received multiple reports of qube monitors failing to boot up or returning to factory default configuration settings following power on or reset.

Spacelabs began to send the Urgent Medical Device Correction XPREZZON Bedside Monitor, Model 91393 qube Compact Monitor, Model 91390 letter, dated 28, January 2015, to US consignees. Spacelabs began sending the Urgent Medical Device Correction XPREZZON Bedside Monitor, Model 91393 qube Compact Monitor, Model 91390 letter (translated as necessary) to international customers via email on 2/4/15. Actions to be Implemented by Users: -Do not rely solely on the monitor for critically ill patients. -If customer facility operates any XPREZZON or qube monitors on a standalone basis, rather than via central monitoring, please contact Spacelabs technical support as these monitors will be the first repaired. Spacelabs Healthcare will contact consignees to schedule a convenient time for Spacelabs to replace the PCBAs in all of your facility's affected XPREZZON and qube monitors at no cost. If you have any questions about this corrective action, please contact Spacelabs at the toll free number of 1-800-522-7025 and select 2 for Technical Support, or via direct dial at 1-425-363-5203.