Device product
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.
Z-1705-2014
Product summary
- Event
- Event 68357
- Status
- Terminated
- Classification
- Class II
- Quantity
- 64 devices
- Official record key
device-enforcement:Z-1705-2014
Official wording
Reason: A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.
Code information: All devices of Model: 91496.
Distribution pattern: US Distribution to GA.
Derived failure modes
-
Device software or design
software anomaly