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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Product Detail

Product Description 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
Classification Class II
Code Info Listing Number: D145750 Model: 91496.
Product Distributed Qty 64 devices
Reason For Recall A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.

Event Detail

Event Id 68357
Product Type Devices
Status Terminated
Recalling Firm Spacelabs Healthcare Inc
City Snoqualmie
State WA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-05-08
Initial Firm Notification of Consignee or Public Visit
Distribution Pattern US Distribution to GA.
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