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Product is the Spacelabs Medical Xprezzon Bedside Monitor… recallZ-1705-2012 · Spacelabs Healthcare, Llc · initiated May 22, 2012

Terminated All recalls posted in June 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Spacelabs Healthcare, Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1705-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 22, 2012
Posted by the FDA
Jun 5, 2012
Recalling firm
Spacelabs Healthcare, Llc
Quantity
1898 monitors (Domestic: 1188) (International: 710)
Product code
MHX
FDA submissions
K112962
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 description

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 (models, lots, serial numbers)

Show the full code information (27k characters)

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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1393-001228; 1393-001229; 1393-001230; 1393-001231; 1393-001232; 1393-001233; 1393-001234; 1393-001235; 1393-001236; 1393-001237; 1393-001238; 1393-001239; 1393-001240; 1393-001241; 1393-001242; 1393-001243; 1393-001244; 1393-001245; 1393-001246; 1393-001247; 1393-001248; 1393-001249; 1393-001250; 1393-001251; 1393-001252; 1393-001253; 1393-001254; 1393-001255; 1393-001256; 1393-001257; 1393-001258; 1393-001259; 1393-001260; 1393-001261; 1393-001262; 1393-001263; 1393-001264; 1393-001265; 1393-001266; 1393-001267; 1393-001268; 1393-001269; 1393-001270; 1393-001271; 1393-001272; 1393-001273; 1393-001274; 1393-001275; 1393-001276; 1393-001277; 1393-001278; 1393-001279; 1393-001280; 1393-001281; 1393-001282; 1393-001283; 1393-001284; 1393-001285; 1393-001286; 1393-001287; 1393-001288; 1393-001289; 1393-001290; 1393-001291; 1393-001292; 1393-001293; 1393-001294; 1393-001295; 1393-001296; 1393-001297; 1393-001298; 1393-001299; 1393-001300; 1393-001301; 1393-001302; 1393-001303; 1393-001308; 1393-001309; 1393-001310; 1393-001311; 1393-001312; 1393-001313; 1393-001314; 1393-001315; 1393-001316; 1393-001317; 1393-001318; 1393-001319; 1393-001320; 1393-001321; 1393-001322; 1393-001323; 1393-001324; 1393-001325; 1393-001326; 1393-001327; 1393-001328; 1393-001329; 1393-001330; 1393-001331; 1393-001332; 1393-001333; 1393-001334; 1393-001335; 1393-001336; 1393-001337; 1393-001338; 1393-001339; 1393-001340; 1393-001341; 1393-001342; 1393-001343; 1393-001344; 1393-001345; 1393-001346; 1393-001347; 1393-001348; 1393-001349; 1393-001350; 1393-001351; 1393-001352; 1393-001353; 1393-001354; 1393-001355; 1393-001356; 1393-001357; 1393-001358; 1393-001359; 1393-001360; 1393-001361; 1393-001362; 1393-001363; 1393-001364; 1393-001365; 1393-001366; 1393-001367; 1393-001368; 1393-001369; 1393-001370; 1393-001371; 1393-001372; 1393-001373; 1393-001374; 1393-001375; 1393-001376; 1393-001377; 1393-001378; 1393-001379; 1393-001380; 1393-001381; 1393-001382; 1393-001383; 1393-001384; 1393-001385; 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.

Other devices under the same FDA submission

2 devices cleared under K112962 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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