Recall Z-1705-2014 ยท DSI Detector And Alarm, Arrhythmia
Spacelabs Healthcare Inc
Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from a patient in a clinical environment.
| Date | Jun 3, 2014 (initiated May 8, 2014) |
| Status | Terminated |
| Reason | A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Spacelabs Healthcare identified a software anomaly in the Ultraview SL" Command Module, Model 91496. During an internal audit, Spacelabs identified a reportable recall that was not reported. We have a product called the Spacelabs Medical Ultraview SL" Command Module, Model 91496. A software error was discovered at a customer site which was not a safety issue, but in the interest of customer service it was decided to downgrade all their modules with an older software version. |
| Quantity | 64 devices |
| Distribution | US Distribution to GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103142 | SPACELABS MULTI-PARAMETER MODULE Spacelabs Healthcare, Inc., Mar 3, 2011 |