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U.S. Department of Health and Human Services

Class 2 Device Recall Spacelabs Medical Xprezzon Bedside Monitor, Model 91393

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  Class 2 Device Recall Spacelabs Medical Xprezzon Bedside Monitor, Model 91393 see related information
Date Initiated by Firm June 12, 2012
Date Posted July 16, 2012
Recall Status1 Terminated 3 on November 28, 2012
Recall Number Z-2019-2012
Recall Event ID 62437
510(K)Number K112962  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms.

The Spacelabs Healthcare Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other devices via Flexport interfaces. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Spacelabs Healthcare Xprezzon Bedside Monitor may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitor allows network based applications to open windows and display information the Xprezzon and other networked monitors. The Spacelabs Healthcare Xprezzon Bedside Monitor is designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Xprezzon Bedside Monitors is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.
Code Information 040-1632-00; 1393-000013; 1393-000039; 1393-000040; 1393-000041; 1393-000341; 1393-000382; 1393-000383; 1393-000384; 1393-000385; 1393-000386; 1393-000387; 1393-000388; 1393-000808; 1393-000831; 1393-001374; 1393-001375; 1393-001453; 1393-001990; 1393-001991; and 1393-001992.
Recalling Firm/
Manufacturer		 Spacelabs Healthcare, Llc
5150 220th Ave Se
Issaquah WA 98029-6834
For Additional Information Contact Spacelabs Healthcare
800-522-7025 Ext. 2
Manufacturer Reason
for Recall		 There were reports that a certain combination of key presses will cause the module to disconnect from the Xprezzon bedside monitor, model 91393, and the patient parameters will drop from the display. The parameters return after power cycling the monitor.
FDA Determined
Cause 2		 Software design
Action Spacelabs Healthcare sent an Urgent Medical Device Correction letter dated June 29 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to advise their staff of the potential failure of the XPREZZON Bedside Monitor. Spacelabs will contact customers to schedule a convenient time for their hospital to upgrade their affected monitors, at no cost. On July 6 2012, a customer letter (translated as necessary) URGENT - MEDICAL DEVICE CORRECTION Spacelabs Healthcare XPREZZON Bedside Monitor will be emailed to all international subsidiaries and distributors of record. Customers with questions can contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support. For questions regarding this recall call 800-522-7025, ext 2.
Quantity in Commerce 21 units
Distribution Worldwide Distribution - USA including Florida, Iowa, Oklahoma, South Caroline and the countries of India, Germany and Panama.
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 = MHX and Original Applicant = SPACELABS MEDICAL INC.
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