Recall Z-0403-2013 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Spacelabs Healthcare, Llc
qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 resolution. The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by 2 Spacelabs Healthcare p
| Date | Nov 20, 2012 (initiated Oct 19, 2012) |
| Status | Terminated |
| Reason | Spacelabs Healthcare has learned through several reports that the input circuit may fail and the monitor will go on battery mode. The monitor will function normally until the batteries become depleted and then the monitor will shut down. In addition the monitor may fail to turn on due to an internal short. |
| Root cause | Nonconforming Material/Component |
| Action | Spacelabs Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated October 19, 2012. The letter identified the product, problem, and actions to be taken by the customers. Contact Spacelabs Healthcare at 1-800522-7025 option 2 for questions regarding this notice. |
| Quantity | 742 total devices distributed; 530 with the U.S. and 212 Internationally. |
| Distribution | Worldwide Distribution.On 4/16/13 the firm advised FDA that they added serial number 1390-000055 and 1390-000913. The two additional serial numbers were added because they were provided as replacements to a French customer whose devices had been returned to support the firm's investigation. The cu |
| 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 |