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.
This recall has been terminated (originally issued June 3, 2014).
- Company
- Spacelabs Healthcare, Inc.
- Recall Initiated
- May 8, 2014
- Posted
- June 3, 2014
- Terminated
- June 3, 2014
- Recall Number
- Z-1705-2014
- Quantity
- 64 devices
- Firm Location
- Snoqualmie, WA
- Official Source
- View on FDA website ↗
Reason for Recall
A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.
Distribution
US Distribution to GA.
Lot / Code Info
All devices of Model: 91496.
Root Cause
Software Manufacturing/Software Deployment
Action Taken
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.