Company: Spacelabs Healthcare Inc
Date of Enforcement Report:6/11/2014
Class lI:
PRODUCT
Spacelabs Medical Ultraview SL” Command Module, Model 91496. Detector and alarm, arrhythmia. 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 (SpO2) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.
Recall Number Z-1705-2014
REASON
A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms..
RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare Inc., Snoqualmie WA on 5/8/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
64 devices p>
DISTRIBUTION
US Distribution to GA
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