510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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Z-1705-2012

Product is the Spacelabs Medical Xprezzon Bedside Monitor, Model 91393. The Xprezzon Bedside Monitor is...

GE Healthcare / initiated 2012-05-22 / Terminated / root cause: design
FDA source (opens on fda.gov)

Spacelabs Healthcare, Llc began a recall of 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... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1705-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GE Healthcare
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.
Product code
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag
design
FDA root 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.
Product codes and lots
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; 1393-000107; 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1393-001386; 1393-001387; 1393-001388; 1393-001389; 1393-001390; 1393-001391; 1393-001392; 1393-001393; 1393-001394; 1393-001395; 1393-001396; 1393-001397; 1393-001398; 1393-001399; 1393-001400; 1393-001401; 1393-001402; 1393-001403; 1393-001404; 1393-001405; 1393-001406; 1393-001407; 1393-001408; 1393-001409; 1393-001410; 1393-001411; 1393-001412; 1393-001413; 1393-001414; 1393-001415; 1393-001416; 1393-001417; 1393-001418; 1393-001419; 1393-001420; 1393-001421; 1393-001422; 1393-001423; 1393-001424; 1393-001425; 1393-001426; 1393-001427; 1393-001428; 1393-001429; 1393-001430; 1393-001431; 1393-001432; 1393-001433; 1393-001434; 1393-001435; 1393-001436; 1393-001437; 1393-001438; 1393-001439; 1393-001440; 1393-001441; 1393-001442; 1393-001443; 1393-001444; 1393-001445; 1393-001446; 1393-001447; 1393-001448; 1393-001449; 1393-001450; 1393-001451; 1393-001452; 1393-001453; 1393-001454; 1393-001455; 1393-001456; 1393-001457; 1393-001458; 1393-001459; 1393-001460; 1393-001461; 1393-001462; 1393-001463; 1393-001464; 1393-001465; 1393-001466; 1393-001467; 1393-001468; 1393-001469; 1393-001470; 1393-001471; 1393-001472; 1393-001478; 1393-001479; 1393-001480; 1393-001481; 1393-001482; 1393-001483; 1393-001484; 1393-001485; 1393-001486; 1393-001487; 1393-001488; 1393-001489; 1393-001490; 1393-001491; 1393-001492; 1393-001493; 1393-001494; 1393-001495; 1393-001496; 1393-001497; 1393-001498; 1393-001499; 1393-001500; 1393-001501; 1393-001502; 1393-001503; 1393-001504; 1393-001505; 1393-001506; 1393-001507; 1393-001508; 1393-001509; 1393-001510; 1393-001511; 1393-001512; 1393-001513; 1393-001514; 1393-001515; 1393-001516; 1393-001517; 1393-001518; 1393-001519; 1393-001520; 1393-001521; 1393-001522; 1393-001523; 1393-001524; 1393-001525; 1393-001526; 1393-001527; 1393-001528; 1393-001529; 1393-001530; 1393-001531; 1393-001532; 1393-001533; 1393-001534; 1393-001535; 1393-001536; 1393-001537; 1393-001538; 1393-001539; 1393-001540; 1393-001541; 1393-001542; 1393-001543; 1393-001544; 1393-001545; 1393-001546; 1393-001547; 1393-001548; 1393-001549; 1393-001550; 1393-001551; 1393-001552; 1393-001553; 1393-001554; 1393-001555; 1393-001556; 1393-001557; 1393-001558; 1393-001559; 1393-001560; 1393-001561; 1393-001562; 1393-001563; 1393-001564; 1393-001565; 1393-001566; 1393-001567; 1393-001568; 1393-001569; 1393-001570; 1393-001571; 1393-001572; 1393-001573; 1393-001574; 1393-001575; 1393-001576; 1393-001577; 1393-001578; 1393-001579; 1393-001580; 1393-001581; 1393-001582; 1393-001583; 1393-001584; 1393-001585; 1393-001586; 1393-001587; 1393-001588; 1393-001589; 1393-001590; 1393-001591; 1393-001592; 1393-001593; 1393-001594; 1393-001595; 1393-001596; 1393-001597; 1393-001598; 1393-001599; 1393-001600; 1393-001601; 1393-001602; 1393-001603; 1393-001604; 1393-001605; 1393-001606; 1393-001607; 1393-001608; 1393-001609; 1393-001610; 1393-001611; 1393-001612; 1393-001613; 1393-001614; 1393-001615; 1393-001616; 1393-001617; 1393-001618; 1393-001619; 1393-001620; 1393-001621; 1393-001622; 1393-001623; 1393-001624; 1393-001625; 1393-001626; 1393-001627; 1393-001628; 1393-001629; 1393-001630; 1393-001631; 1393-001632; 1393-001633; 1393-001634; 1393-001635; 1393-001636; 1393-001637; 1393-001638; 1393-001639; 1393-001640; 1393-001641; 1393-001642; 1393-001644; 1393-001645; 1393-001646; 1393-001647; 1393-001648; 1393-001649; 1393-001650; 1393-001651; 1393-001652; 1393-001653; 1393-001654; 1393-001655; 1393-001656; 1393-001657; 1393-001658; 1393-001659; 1393-001660; 1393-001661; 1393-001662; 1393-001663; 1393-001664; 1393-001681; 1393-001682; 1393-001683; 1393-001684; 1393-001685; 1393-001686; 1393-001687; 1393-001688; 1393-001689; 1393-001690; 1393-001691; 1393-001692; 1393-001693; 1393-001694; 1393-001695; 1393-001696; 1393-001697; 1393-001698; 1393-001699; 1393-001700; 1393-001701; 1393-001702; 1393-001703; 1393-001704; 1393-001705; 1393-001706; 1393-001707; 1393-001708; 1393-001709; 1393-001710; 1393-001711; 1393-001712; 1393-001713; 1393-001714; 1393-001715; 1393-001716; 1393-001717; 1393-001718; 1393-001719; 1393-001720; 1393-001721; 1393-001722; 1393-001723; 1393-001724; 1393-001725; 1393-001726; 1393-001727; 1393-001728; 1393-001729; 1393-001730; 1393-001731; 1393-001732; 1393-001733; 1393-001734; 1393-001735; 1393-001736; 1393-001737; 1393-001738; 1393-001739; 1393-001740; 1393-001741; 1393-001742; 1393-001743; 1393-001744; 1393-001745; 1393-001746; 1393-001747; 1393-001748; 1393-001749; 1393-001750; 1393-001751; 1393-001752; 1393-001753; 1393-001754; 1393-001755; 1393-001756; 1393-001757; 1393-001758; 1393-001759; 1393-001760; 1393-001761; 1393-001762; 1393-001763; 1393-001764; 1393-001765; 1393-001766; 1393-001767; 1393-001768; 1393-001769; 1393-001770; 1393-001771; 1393-001772; 1393-001773; 1393-001774; 1393-001775; 1393-001776; 1393-001777; 1393-001778; 1393-001779; 1393-001780; 1393-001781; 1393-001782; 1393-001783; 1393-001784; 1393-001785; 1393-001786; 1393-001787; 1393-001788; 1393-001789; 1393-001790; 1393-001791; 1393-001792; 1393-001793; 1393-001794; 1393-001795; 1393-001796; 1393-001797; 1393-001798; 1393-001799; 1393-001800; 1393-001801; 1393-001802; 1393-001803; 1393-001804; 1393-001805; 1393-001806; 1393-001807; 1393-001808; 1393-001809; 1393-001810; 1393-001811; 1393-001812; 1393-001813; 1393-001814; 1393-001815; 1393-001816; 1393-001817; 1393-001818; 1393-001819; 1393-001820; 1393-001821; 1393-001822; 1393-001823; 1393-001824; 1393-001825; 1393-001826; 1393-001827; 1393-001828; 1393-001829; 1393-001830; 1393-001831; 1393-001832; 1393-001833; 1393-001834; 1393-001835; 1393-001836; 1393-001837; 1393-001838; 1393-001839; 1393-001840; 1393-001841; 1393-001842; 1393-001843; 1393-001844; 1393-001845; 1393-001846; 1393-001847; 1393-001848; 1393-001849; 1393-001850; 1393-001851; 1393-001852; 1393-001853; 1393-001854; 1393-001855; 1393-001856; 1393-001857; 1393-001858; 1393-001859; 1393-001860; 1393-001861; 1393-001862; 1393-001863; 1393-001864; 1393-001865; 1393-001866; 1393-001867; 1393-001868; 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; 1393-002067; 1393-002068; 1393-002069; 1393-002070; 1393-002071; 1393-002072; 1393-002073; 1393-002074; 1393-002075; 1393-002076; 1393-002077; 1393-002078; 1393-002079; 1393-002080; 1393-002081; 1393-002082; 1393-002083; 1393-002084; 1393-002085; 1393-002086; 1393-002087; 1393-002088; 1393-002089; 1393-002090; 1393-002091; 1393-002092; 1393-002093; 1393-002094; 1393-002095; 1393-002096; 1393-002097; 1393-002098; 1393-002099; 1393-002100; 1393-002101; 1393-002102; 1393-002103; 1393-002104; 1393-002105; 1393-002106; 1393-002107; 1393-002108; 1393-002109; 1393-002110; 1393-002111; 1393-002112; 1393-002113; 1393-002114; 1393-002115; 1393-002116; 1393-002117; 1393-002118; 1393-002119; 1393-002120; 1393-002121; 1393-002122; 1393-002123; 1393-002124; 1393-002125; 1393-002126; 1393-002127; 1393-002128; 1393-002129; 1393-002130; 1393-002131; 1393-002132; 1393-002133; 1393-002134; 1393-002135; 1393-002136; 1393-002137; 1393-002138; 1393-002139; 1393-002140; 1393-002141; 1393-002142; 1393-002143; 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.