Class 2 Device Recall Model 91393, Xprezzon Bedside Monitor

• Date Initiated by Firm: May 22, 2012
• Date Posted: June 05, 2012
• Recall Status: Terminated on May 07, 2013
• Recall Number: Z-1705-2012
• Recall Event ID: 61919
• 510(K)Number: K112962
• Product Classification: Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
• Product: Product is the Spacelabs Medical Xprezzon Bedside Monitor, Model 91393.; ; The 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. It can also function as a generic display or computer terminal. It 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. It passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLC based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on this model, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, SpO2, temperature and cardiac output.
• Code Information: Serial Numbers: 1393-000013; 1393-000016; 1393-000019; 1393-000027; 1393-000031; 1393-000034; 1393-000035; 1393-000039; 1393-000040; 1393-000041; 1393-000042; 1393-000043; 1393-000044; 1393-000045; 1393-000046; 1393-000047; 1393-000048; 1393-000049; 1393-000050; 1393-000051; 1393-000052; 1393-000053; 1393-000054; 1393-000055; 1393-000056; 1393-000057; 1393-000058; 1393-000059; 1393-000060; 1393-000061; 1393-000062; 1393-000063; 1393-000064; 1393-000065; 1393-000066; 1393-000067; 1393-000068; 1393-000069; 1393-000070; 1393-000071; 1393-000072; 1393-000073; 1393-000074; 1393-000075; 1393-000076; 1393-000077; 1393-000078; 1393-000079; 1393-000080; 1393-000081; 1393-000082; 1393-000083; 1393-000084; 1393-000085; 1393-000086; 1393-000087; 1393-000088; 1393-000089; 1393-000090; 1393-000091; 1393-000092; 1393-000093; 1393-000094; 1393-000095; 1393-000096; 1393-000097; 1393-000098; 1393-000099; 1393-000100; 1393-000101; 1393-000102; 1393-000103; 1393-000104; 1393-000105; 1393-000106; 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1393-001869; 1393-001870; 1393-001871; 1393-001872; 1393-001873; 1393-001874; 1393-001875; 1393-001876; 1393-001877; 1393-001878; 1393-001879; 1393-001880; 1393-001881; 1393-001882; 1393-001883; 1393-001884; 1393-001885; 1393-001886; 1393-001887; 1393-001888; 1393-001889; 1393-001890; 1393-001891; 1393-001892; 1393-001893; 1393-001894; 1393-001895; 1393-001896; 1393-001897; 1393-001898; 1393-001899; 1393-001900; 1393-001901; 1393-001902; 1393-001903; 1393-001904; 1393-001905; 1393-001906; 1393-001907; 1393-001908; 1393-001909; 1393-001910; 1393-001911; 1393-001912; 1393-001913; 1393-001914; 1393-001915; 1393-001916; 1393-001917; 1393-001918; 1393-001949; 1393-001950; 1393-001951; 1393-001952; 1393-001953; 1393-001954; 1393-001955; 1393-001956; 1393-001957; 1393-001958; 1393-001960; 1393-001961; 1393-001962; 1393-001963; 1393-001964; 1393-001965; 1393-001966; 1393-001967; 1393-001968; 1393-001969; 1393-001970; 1393-001971; 1393-001972; 1393-001973; 1393-001974; 1393-001975; 1393-001976; 1393-001977; 1393-001978; 1393-001979; 1393-001980; 1393-001987; 1393-001988; 1393-001989; 1393-001990; 1393-001991; 1393-001992; 1393-001993; 1393-001994; 1393-001995; 1393-001996; 1393-001997; 1393-001998; 1393-001999; 1393-002000; 1393-002001; 1393-002002; 1393-002003; 1393-002004; 1393-002012; 1393-002013; 1393-002014; 1393-002015; 1393-002016; 1393-002017; 1393-002018; 1393-002019; 1393-002020; 1393-002021; 1393-002022; 1393-002023; 1393-002024; 1393-002025; 1393-002026; 1393-002027; 1393-002028; 1393-002029; 1393-002030; 1393-002031; 1393-002032; 1393-002033; 1393-002034; 1393-002035; 1393-002036; 1393-002037; 1393-002038; 1393-002039; 1393-002040; 1393-002041; 1393-002042; 1393-002043; 1393-002044; 1393-002045; 1393-002046; 1393-002047; 1393-002048; 1393-002049; 1393-002050; 1393-002051; 1393-002052; 1393-002053; 1393-002054; 1393-002055; 1393-002056; 1393-002057; 1393-002058; 1393-002059; 1393-002060; 1393-002061; 1393-002062; 1393-002063; 1393-002064; 1393-002065; 1393-002066; 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1393-002144; 1393-002145; 1393-002146; 1393-002147; 1393-002148; 1393-002149; 1393-002150; 1393-002151; 1393-002152; 1393-002153; 1393-002154; 1393-002155; 1393-002156; 1393-002157; 1393-002158; 1393-002159; 1393-002160; 1393-002161; 1393-002162; 1393-002163; 1393-002164; 1393-002167; 1393-002168; 1393-002169; 1393-002170; 1393-002171; 1393-002172; 1393-002173; 1393-002174; 1393-002175; 1393-002176; 1393-002177; 1393-002178; 1393-00235; 1393-00236; 1393-00237; 1393-00238; 1393-00239; 1393-00240; 1393-00241; 1393-00335; 1393-00346; 1393-00347; 1393-00348; 1393-00349; 1393-00350; 1393-00351; 1393-00352; 1393-00353; 1393-00354; 1393-00355; and 1393-1130032.
• Recalling Firm/ Manufacturer: Spacelabs Healthcare, Llc; 5150 220th Ave Se; Issaquah WA 98029-6834
• For Additional Information Contact: Al Van Houdt; 425-657-7200 Ext. 5970
• Manufacturer Reason for Recall: The screw used to connect the external power supply to the Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, may damage an internal capacitor. The damage may result in an inability of the monitor to power on, power off, or involuntarily shut down.
• FDA Determined Cause: Device Design
• Action: The firm, Spacelabs Healthcare, sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated May 22, 2012 via return receipt requested, to US customers. On May 29, 2012 a translated customer letter was emailed to all international subsidiaries and distributors of record. The letter describes the product, problem and actions to be taken. The customers were instructed to notify staff of the potential failure and to only tighten the power supply screw with their fingers. In addition, the firm will schedule a time to upgrade the monitors at the customers site. If you have any questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.
• Quantity in Commerce: 1898 monitors (Domestic: 1188) (International: 710)
• Distribution: Worldwide distribution: USA (nationwide) and countries including: Australia, Canada, Chile, China, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, India, Italy, Kuwait, Malaysia, Netherlands, Panama, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Switzerland, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
• 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.