Recall Z-0351-2014 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Spacelabs Healthcare, Llc
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube 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. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. hi
| Date | Nov 18, 2013 (initiated Oct 17, 2013) |
| Status | Terminated |
| Reason | Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component. |
| Root cause | Nonconforming Material/Component |
| Action | Spacelabs Healthcare sent the "URGENT -MEDICAL DEVICE CORRECTION Spacelabs Healthcare qube Compact Monitor" letter, dated 01 November 2013, to the US consignees/customers on November 1, 2013. Spacelabs Healthcare will send the customer letter (translated as necessary) to all international subsidiaries and distributors of record via email on November 6, 2013. The letter described the product, problem and actions to be taken. The customers were instructed to advise staff of the potential for the monitor to fail to turn ON. Spacelabs Healthcare will contact their customers at the earliest possi |
| Quantity | 54 units total (42 units in the US and 12 outside US) |
| Distribution | Worldwide distribution: US (nationwide) including states of: Georgia, Idaho, New York, Oklahoma, Tennessee, Texas, and Wyoming and in countries of: Bahrain, Canada, France, Great Britain, Poland, and The Netherlands. |
| 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 |