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.
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FDA Device · Class II · 2026-08-19 · Spacelabs Healthcare - Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product…
FDA Device · Class II · 2026-05-13 · Spacelabs Healthcare - Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Device · Class II · 2026-04-15 · Spacelabs Healthcare - Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology In…
FDA Device · Class II · 2025-11-12 · Spacelabs Healthcare - Brand Name: Branding is not applied to this product
FDA Device · Class II · 2025-10-22 · Spacelabs Healthcare
All Spacelabs Healthcare recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1705-2014%22
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