Recall Z-0776-2012 ยท DSI Detector And Alarm, Arrhythmia
Spacelabs Healthcare, Llc
Spacelabs Medical Ultraview SL Command Module, Model 91496. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmi
| Date | Jan 17, 2012 (initiated Jul 13, 2011) |
| Status | Terminated |
| Reason | One Spacelabs Medical Ultraview SL Command Module, Model 91496, was removed from customer due to software error. |
| Root cause | Software design |
| Action | Spacelabs removed one affected unit of Medical Ultraview SL Command Module from a hospital in Troy, MI. during a site visit on July 13, 2011. This recall pertains to one single unit at one location. Contact Spacelabs at 425-657-7200 for questions regarding this recall. |
| Quantity | one unit |
| Distribution | One device distributed in Troy, MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103142 | SPACELABS MULTI-PARAMETER MODULE Spacelabs Healthcare, Inc., Mar 3, 2011 |