Class 2 Device Recall Command Module

• Date Initiated by Firm: July 22, 2008
• Date Posted: September 19, 2008
• Recall Status: Terminated on July 25, 2011
• Recall Number: Z-2342-2008
• Recall Event ID: 48759
• 510(K)Number: K972502
• Product Classification: Arrhythmia Detector and alarm - Product Code DSI
• Product: Ultraview SL Command Module, Model 90496; The product is intended for use with the Patient Care Monitoring 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 cardiac activity, respiration, invasive and noninvasive pressure, temperature, oxygen saturation (SpO2) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.
• Code Information: Serial Numbers 496-053539, 496-053540, 496-053541, 496-053591, 496-053592, 496-053593, 496-053595, 496-053596, 496-053542, 496-053551, 496-053552, 496-053547, 496-053548, 496-053459, 496-053460, 496-053461, 496-053462, 496-053463, 496-053464, 496-053544, 496-053545, 496-053546, 496-053467, 496-053468, 496-053469, 496-053471, 496-053457, 496-053458, 496-053388, 496-053389, 496-053370, 496-053275, 496-053276, 496-053277, 496-053278, 496-053279, 496-053280, 496-053281, 496-053282, 496-053283, 496-053286, 496-053304, 496-053305, 496-053306, 496-053307, 496-053308, 496-053309, 496-053310, 496-053311, 496-053312, 496-053313, 496-053314, 496-053315, 496-053316, 496-053317, 496-053253, 496-053254, 496-053255, 496-053256, 496-053257, 496-053258, 496-053259, 496-053260, 496-053261, 496-053262, 496-053263, 496-053264, 496-053265, 496-053266, 496-053267, 496-053268, 496-053269, 496-053270, 496-053271, 496-053272, 496-053273, 496-053274, 496-053227, 496-053228, 496-053230, 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• Recalling Firm/ Manufacturer: Spacelabs Healthcare, Incorporated; 5150 220th Ave Se; Issaquah WA 98029-6834
• For Additional Information Contact: 425-657-7200 Ext. 5970
• Manufacturer Reason for Recall: Potential for module to fail to obtain a NIBP reading on hypertension patients.
• FDA Determined Cause: Process control
• Action: On July 22, 2008 an "Urgent MEDICAL DEVICE CORRECTION" letter was mailed to all the firm's customers. The letter states the problem at hand, when the problem would likely to occur and instructions of a way to mitigate the risk, until the modules can be recalibrated . The firm's Customer Connectivity Center will confirm all affected customers have been notified. Spacelabs Technical Support will be recalibrating all modules personally and ensuring all corrections have been applied to all affected customers of record. Contact Spacelabs Healthcare at 1-800-522-7025 for assistance.
• Quantity in Commerce: 5,140
• Distribution: The product is distributed nationwide and internationally to medical facilities.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DSI and Original Applicant = SPACELABS MEDICAL, INC.