FDA Device recall Z-1542-2015
Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option
- FDA Device
- Class II
- terminated
- Published 2015-05-06
On 2015-05-06 the FDA classified a Class II recall of Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option by Spacelabs Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1542-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-17 |
| Published | 2015-05-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spacelabs Healthcare |
| Distribution | US |
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
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.
Identifiers
| code_info | SERIAL NUMBERS IN THE US: 1496-000473, 1496-000590, 1496-001126, 1496-001189, 1496-001214, 1496-001299, 1496-001300,…SERIAL NUMBERS IN THE US: 1496-000473, 1496-000590, 1496-001126, 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, 1496-001713, 1496-001714, 1496-002442, 1496-002568, 1496-002691, 1496-002743, 1496-002832, 1496-002833, 1496-002834, 1496-002836, 1496-002837, 1496-002838, 1496-002839, 1496-002840, 1496-002841, 1496-002917, 1496-002918, 1496-002919, 1496-002920, 1496-002998, 1496-002999, 1496-003000, 1496-003001, 1496-003002, 1496-003003, 1496-003005, 1496-003006, 1496-003007, 1496-003021, 1496-003022, 1496-003025, 1496-003035, 1496-003036, 1496-003037, 1496-003042, 1496-003043, 1496-003044, 1496-003046, 1496-003049, 1496-003051, 1496-003055, 1496-003158, 1496-003161, 1496-003162, 1496-003163, 1496-003164, 1496-003179, 1496-003187, 1496-003190, 1496-003191, 1496-0031 |
|---|
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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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1542-2015%22
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