Ultraview SL Command Modules — Class II medical device recall Z-1542-2015
Terminated recall by Spacelabs Healthcare Inc, reported 2015-05-06, distributed nationwide. Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was affected. Cust
| Recall number | Z-1542-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spacelabs Healthcare Inc, Snoqualmie, WA, United States |
| Recall initiated | 2015-04-17 |
| Classified | 2015-04-28 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2015-11-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR |
| Serial numbers | 1496-000473, 1496-000590, 1496-001126, 1496-001139, 1496-001189, 1496-001214, 1496-001299, 1496-001300, 1496-001301, 1496-001302, 1496-001303, 1496-001304, 1496-001305, 1496-001306, 1496-001307, 1496-001309, 1496-001328, 1496-001329, 1496-001330, 1496-001332, 1496-001333, 1496-001335, 1496-001336, 1496-001337, 1496-001712 and 475 more |
| Model numbers | 91496-M |
Product
Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.
Reason for recall
Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was affected. Customer reported that during the time that the module is resetting (~10 seconds), monitoring of all parameters will be suspended. Upon completion of this sequence, alarms will be reset to their default values.
Machine access
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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.