Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ultraview SL Command Modules Recalled by Spacelabs Healthcare Inc Due to Ultraview SL Command Modules which were upgraded with...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Spacelabs Healthcare Inc directly.
Affected Products
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.
Quantity: 1999 units total (1932 in the US and 67 international)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Spacelabs Healthcare Inc
Spacelabs Healthcare Inc has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report