Recall Z-1145-2015 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Spacelabs Healthcare Inc
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
| Date | Feb 24, 2015 (initiated Jan 28, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | total 2955 units (2117 units in US and 838 units outside US) |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120616 | SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390 Spacelabs Medical, Inc., Mar 29, 2012 |