Spacelabs Medical Ultraview SL Command Module — Class II medical device recall Z-1705-2014
Terminated recall by Spacelabs Healthcare Inc, reported 2014-06-11. A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible
| Recall number | Z-1705-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spacelabs Healthcare Inc, Snoqualmie, WA, United States |
| Recall initiated | 2014-05-08 |
| Classified | 2014-06-03 |
| Reported by FDA | 2014-06-11 |
| Terminated | 2014-06-03 |
| Quantity | 64 devices |
| Reason classes | software |
| Model numbers | 91496 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1705-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.