Ultraview SL Command Modules — Class II medical device recall Z-1577-2015
Terminated recall by Spacelabs Healthcare Inc, reported 2015-05-13, distributed nationwide. Modules resetting. This failure mode happens when the Spacelabs Command Module is configured with the Masimo S
| Recall number | Z-1577-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spacelabs Healthcare Inc, Snoqualmie, WA, United States |
| Recall initiated | 2015-04-21 |
| Classified | 2015-05-04 |
| Reported by FDA | 2015-05-13 |
| Terminated | 2015-11-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BD, CA, CL, FR, GB, IN, KW, PA, PL, QA, SA, TR |
| Serial numbers | 1496-005416, 1496-005717, 1496-005727, 1496-005734, 1496-005735, 1496-005737, 1496-005739, 1496-005744, 1496-005745, 1496-005746, 1496-005760, 1496-008609, 1496-008614, 1496-008918, 1496-009096, 1496-009666, 1496-010906, 1496-014637, 1496-022087, 1496-023491, 1496-034466, 1496-036281, 1496-044908, 1496-103794, 1496-109373 and 4 more |
| Model numbers | 91496 |
Product
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. 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.
Reason for recall
Modules resetting. This failure mode happens when the Spacelabs Command Module is configured with the Masimo SpO2 option (-M), the Spacelabs Respiration option (-R) and the Masimo SpO2 PCBA, PN: 010-1136-02. With these two options and the Masimo SpO2 PCBA present, the module may experience random resets.
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-1577-2015. 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.