FDA-Device2014-06-11Class II
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.
Spacelabs Healthcare Inc
Hazard
A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.
Sold states
US Distribution to GA.
Affected count
64 devices
Manufactured in
35301 SE Center St, Snoqualmie, WA, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1705-2014Don't want to check this manually?
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