Recall Z-0523-2007 ยท DSI Detector And Alarm, Arrhythmia
Spacelabs Healthcare, Incorporated
Ultraview SL Command Module with Masimo Sp02 Option, a multiparameter patient monitor.
| Date | Feb 27, 2007 (initiated Jan 3, 2007) |
| Status | Terminated |
| Reason | Potential for modules to reset, alarms returning to default settings, invasive pressure losing its labels and zero calibration and Sp02 alarm limits being frozen. This can result in delay in treatment. |
| Root cause | Other |
| Action | On 1/3/07 the firm issued a letter to their customers advising of the issues and provided guidance to the consignee to enable the Check Setup feature that will provide an audible prompt whenever the monitor resets. The letter advises that consignees will be contacted to schedule an update, once new software has been validated. |
| Quantity | 1347 devices; 1067 domestic and 280 international |
| Distribution | Nationwide and worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050605 | SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 Spacelabs Medical, Inc., May 3, 2005 |