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U.S. Department of Health and Human Services

Class 2 Device Recall Spacelabs Medical Ultraview SL Command Module, Model 91496

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  Class 2 Device Recall Spacelabs Medical Ultraview SL Command Module, Model 91496 see related information
Date Initiated by Firm July 13, 2011
Date Posted January 17, 2012
Recall Status1 Terminated 3 on January 20, 2012
Recall Number Z-0776-2012
Recall Event ID 60764
510(K)Number K103142  
Product Classification Detector and alarm, arrhythmia - Product Code DSI
Product Spacelabs Medical Ultraview SL Command Module, Model 91496.

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.
Code Information Serial number: 1496-029792
Recalling Firm/
Manufacturer		 Spacelabs Healthcare, Llc
5150 220th Ave Se
Issaquah WA 98029-6834
For Additional Information Contact David J. Geraghty
425-657-7200 Ext. 5970
Manufacturer Reason
for Recall		 One Spacelabs Medical Ultraview SL Command Module, Model 91496, was removed from customer due to software error.
FDA Determined
Cause 2		 Software design
Action Spacelabs removed one affected unit of Medical Ultraview SL Command Module from a hospital in Troy, MI. during a site visit on July 13, 2011. This recall pertains to one single unit at one location. Contact Spacelabs at 425-657-7200 for questions regarding this recall.
Quantity in Commerce one unit
Distribution One device distributed in Troy, MI.
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 HEALTHCARE, INC.
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