FDA Device recall Z-1577-2015
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02
- FDA Device
- Class II
- terminated
- Published 2015-05-13
On 2015-05-13 the FDA classified a Class II recall of Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02 by Spacelabs Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1577-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-21 |
| Published | 2015-05-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spacelabs Healthcare |
| Distribution | US |
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
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.
Identifiers
| code_info | FIRM EXPANDED RECALL ON JUNE 4, 2015 TO INCLUDE ADDITIONAL 29 SERIAL NUMBERS IN THE US: 1496-005416, 1496-005717, 14…FIRM EXPANDED RECALL ON JUNE 4, 2015 TO INCLUDE ADDITIONAL 29 SERIAL NUMBERS IN THE US: 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, 1496-109960, 1496-120322, 1496-122842, and 1496-127070. ******************************************************************************************* PCPA PN: 010-1636-02 **************SERIAL NUMBERS OF MODULES IN THE US****************** 1496-000595, 1496-005414, 1496-005702, 1496-005703, 1496-005704, 1496-005708, 1496-005710, 1496-005713, 1496-005714, 1496-005743, 1496-005748, 1496-005759, 1496-005786, 1496-006113, 1496-008032, 1496-008591, 1496-008595, 1496-008598, 1496-008599, 1496-008601, 1496-008602, 1496-008603, 1496-008605, 1496-008607, 1496-008615, 1496-0086 |
|---|
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
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FDA Device · Class II · 2025-11-12 · Spacelabs Healthcare - Brand Name: Branding is not applied to this product
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1577-2015%22
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