FDA Device recall Z-1705-2014
Spacelabs Medical Ultraview SL Command Module, Model 91496
- FDA Device
- Class II
- terminated
- Published 2014-06-11
On 2014-06-11 the FDA classified a Class II recall of Spacelabs Medical Ultraview SL Command Module, Model 91496 by Spacelabs Healthcare, citing A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1705-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-08 |
| Published | 2014-06-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spacelabs Healthcare |
| Distribution | GA |
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.
Reason
A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.
Identifiers
| code_info | All devices of Model: 91496. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1705-2014%22
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