Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Spacelabs Medical Ultraview SL Command Module Recalled by Spacelabs Healthcare Inc Due to A software anomaly causes temperature alarm limits to...
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
Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from a patient in a clinical environment.
Quantity: 64 devices
Why Was This Recalled?
A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.
Where Was This Sold?
This product was distributed to 1 state: GA
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