Device Recall Model 91393, Xprezzon Bedside Monitor

  • Modelo / Serial
    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; 1393-000108; 1393-000109; 1393-000110; 1393-000111; 1393-000112; 1393-000113; 1393-000114; 1393-000115; 1393-000116; 1393-000117; 1393-000118; 1393-000119; 1393-000120; 1393-000121; 1393-000122; 1393-000123; 1393-000124; 1393-000125; 1393-000126; 1393-000127; 1393-000128; 1393-000129; 1393-000130; 1393-000131; 1393-000132; 1393-000133; 1393-000134; 1393-000135; 1393-000136; 1393-000137; 1393-000138; 1393-000139; 1393-000140; 1393-000141; 1393-000142; 1393-000143; 1393-000144; 1393-000145; 1393-000146; 1393-000147; 1393-000148; 1393-000149; 1393-000150; 1393-000151; 1393-000173; 1393-000188; 1393-000189; 1393-000194; 1393-000200; 1393-000201; 1393-000202; 1393-000203; 1393-000204; 1393-000205; 1393-000206; 1393-000207; 1393-000208; 1393-000210; 1393-000211; 1393-000212; 1393-000213; 1393-000214; 1393-000215; 1393-000216; 1393-000217; 1393-000218; 1393-000222; 1393-000223; 1393-000224; 1393-000225; 1393-000226; 1393-000227; 1393-000228; 1393-000229; 1393-000230; 1393-000231; 1393-000233; 1393-000234; 1393-000247; 1393-000249; 1393-000250; 1393-000251; 1393-000252; 1393-000253; 1393-000254; 1393-000255; 1393-000256; 1393-000257; 1393-000258; 1393-000259; 1393-000260; 1393-000261; 1393-000262; 1393-000263; 1393-000264; 1393-000265; 1393-000266; 1393-000267; 1393-000268; 1393-000269; 1393-000270; 1393-000271; 1393-000272; 1393-000273; 1393-000274; 1393-000275; 1393-000276; 1393-000277; 1393-000278; 1393-000279; 1393-000280; 1393-000281; 1393-000282; 1393-000283; 1393-000284; 1393-000285; 1393-000286; 1393-000287; 1393-000288; 1393-000289; 1393-000290; 1393-000291; 1393-000292; 1393-000293; 1393-000294; 1393-000295; 1393-000296; 1393-000297; 1393-000298; 1393-000299; 1393-000300; 1393-000301; 1393-000302; 1393-000303; 1393-000304; 1393-000305; 1393-000306; 1393-000307; 1393-000308; 1393-000309; 1393-000310; 1393-000311; 1393-000312; 1393-000313; 1393-000314; 1393-000315; 1393-000316; 1393-000317; 1393-000318; 1393-000319; 1393-000320; 1393-000321; 1393-000322; 1393-000323; 1393-000324; 1393-000325; 1393-000326; 1393-000327; 1393-000328; 1393-000329; 1393-000330; 1393-000331; 1393-000332; 1393-000333; 1393-000334; 1393-000336; 1393-000337; 1393-000338; 1393-000339; 1393-000340; 1393-000341; 1393-000342; 1393-000343; 1393-000344; 1393-000345; 1393-000356; 1393-000357; 1393-000358; 1393-000359; 1393-000360; 1393-000361; 1393-000362; 1393-000363; 1393-000364; 1393-000365; 1393-000366; 1393-000367; 1393-000368; 1393-000369; 1393-000370; 1393-000371; 1393-000372; 1393-000373; 1393-000374; 1393-000375; 1393-000376; 1393-000377; 1393-000378; 1393-000379; 1393-000380; 1393-000381; 1393-000382; 1393-000383; 1393-000384; 1393-000385; 1393-000386; 1393-000387; 1393-000388; 1393-000389; 1393-000391; 1393-000392; 1393-000393; 1393-000394; 1393-000395; 1393-000396; 1393-000397; 1393-000398; 1393-000399; 1393-000400; 1393-000401; 1393-000402; 1393-000403; 1393-000404; 1393-000405; 1393-000406; 1393-000407; 1393-000408; 1393-000409; 1393-000410; 1393-000411; 1393-000412; 1393-000413; 1393-000414; 1393-000415; 1393-000416; 1393-000417; 1393-000418; 1393-000419; 1393-000420; 1393-000421; 1393-000422; 1393-000423; 1393-000424; 1393-000425; 1393-000426; 1393-000427; 1393-000428; 1393-000429; 1393-000430; 1393-000431; 1393-000432; 1393-000433; 1393-000434; 1393-000435; 1393-000436; 1393-000437; 1393-000438; 1393-000439; 1393-000440; 1393-000441; 1393-000442; 1393-000443; 1393-000448; 1393-000449; 1393-000450; 1393-000451; 1393-000452; 1393-000453; 1393-000454; 1393-000455; 1393-000456; 1393-000457; 1393-000458; 1393-000459; 1393-000460; 1393-000461; 1393-000462; 1393-000463; 1393-000464; 1393-000465; 1393-000466; 1393-000467; 1393-000468; 1393-000469; 1393-000470; 1393-000471; 1393-000472; 1393-000473; 1393-000474; 1393-000475; 1393-000476; 1393-000477; 1393-000478; 1393-000479; 1393-000480; 1393-000481; 1393-000482; 1393-000483; 1393-000484; 1393-000485; 1393-000486; 1393-000487; 1393-000488; 1393-000489; 1393-000490; 1393-000491; 1393-000492; 1393-000493; 1393-000494; 1393-000495; 1393-000496; 1393-000497; 1393-000501; 1393-000503; 1393-000508; 1393-000509; 1393-000510; 1393-000511; 1393-000512; 1393-000513; 1393-000514; 1393-000515; 1393-000516; 1393-000517; 1393-000518; 1393-000519; 1393-000520; 1393-000521; 1393-000522; 1393-000523; 1393-000524; 1393-000525; 1393-000526; 1393-000527; 1393-000528; 1393-000529; 1393-000530; 1393-000531; 1393-000532; 1393-000533; 1393-000534; 1393-000535; 1393-000536; 1393-000537; 1393-000538; 1393-000539; 1393-000540; 1393-000541; 1393-000542; 1393-000543; 1393-000544; 1393-000545; 1393-000546; 1393-000547; 1393-000548; 1393-000549; 1393-000550; 1393-000551; 1393-000552; 1393-000553; 1393-000554; 1393-000555; 1393-000556; 1393-000557; 1393-000558; 1393-000559; 1393-000560; 1393-000561; 1393-000562; 1393-000563; 1393-000564; 1393-000565; 1393-000566; 1393-000567; 1393-000568; 1393-000569; 1393-000570; 1393-000571; 1393-000572; 1393-000573; 1393-000574; 1393-000575; 1393-000576; 1393-000577; 1393-000578; 1393-000579; 1393-000580; 1393-000581; 1393-000582; 1393-000583; 1393-000584; 1393-000585; 1393-000586; 1393-000587; 1393-000588; 1393-000589; 1393-000590; 1393-000591; 1393-000592; 1393-000593; 1393-000594; 1393-000595; 1393-000596; 1393-000597; 1393-000598; 1393-000599; 1393-000600; 1393-000601; 1393-000602; 1393-000603; 1393-000604; 1393-000605; 1393-000606; 1393-000607; 1393-000608; 1393-000609; 1393-000610; 1393-000611; 1393-000612; 1393-000613; 1393-000614; 1393-000615; 1393-000616; 1393-000617; 1393-000618; 1393-000619; 1393-000620; 1393-000621; 1393-000623; 1393-000624; 1393-000625; 1393-000626; 1393-000627; 1393-000628; 1393-000629; 1393-000630; 1393-000631; 1393-000632; 1393-000633; 1393-000634; 1393-000635; 1393-000636; 1393-000637; 1393-000638; 1393-000639; 1393-000640; 1393-000641; 1393-000642; 1393-000643; 1393-000644; 1393-000645; 1393-000646; 1393-000647; 1393-000648; 1393-000649; 1393-000650; 1393-000701; 1393-000702; 1393-000703; 1393-000704; 1393-000705; 1393-000706; 1393-000707; 1393-000708; 1393-000709; 1393-000710; 1393-000711; 1393-000712; 1393-000713; 1393-000714; 1393-000715; 1393-000716; 1393-000717; 1393-000718; 1393-000719; 1393-000720; 1393-000721; 1393-000722; 1393-000723; 1393-000724; 1393-000725; 1393-000726; 1393-000727; 1393-000728; 1393-000729; 1393-000730; 1393-000731; 1393-000732; 1393-000733; 1393-000734; 1393-000735; 1393-000736; 1393-000737; 1393-000738; 1393-000739; 1393-000740; 1393-000741; 1393-000742; 1393-000743; 1393-000744; 1393-000745; 1393-000746; 1393-000747; 1393-000748; 1393-000749; 1393-000750; 1393-000751; 1393-000752; 1393-000753; 1393-000754; 1393-000755; 1393-000756; 1393-000757; 1393-000758; 1393-000759; 1393-000760; 1393-000761; 1393-000762; 1393-000763; 1393-000764; 1393-000765; 1393-000766; 1393-000767; 1393-000768; 1393-000769; 1393-000770; 1393-000771; 1393-000772; 1393-000773; 1393-000774; 1393-000775; 1393-000776; 1393-000777; 1393-000778; 1393-000779; 1393-000780; 1393-000781; 1393-000782; 1393-000783; 1393-000784; 1393-000785; 1393-000786; 1393-000787; 1393-000788; 1393-000789; 1393-000790; 1393-000792; 1393-000793; 1393-000794; 1393-000795; 1393-000796; 1393-000797; 1393-000798; 1393-000799; 1393-000800; 1393-000801; 1393-000802; 1393-000803; 1393-000804; 1393-000805; 1393-000806; 1393-000807; 1393-000808; 1393-000809; 1393-000810; 1393-000811; 1393-000812; 1393-000813; 1393-000814; 1393-000815; 1393-000816; 1393-000817; 1393-000818; 1393-000819; 1393-000820; 1393-000821; 1393-000822; 1393-000826; 1393-000827; 1393-000828; 1393-000830; 1393-000831; 1393-000832; 1393-000833; 1393-000834; 1393-000835; 1393-000836; 1393-000837; 1393-000838; 1393-000839; 1393-000840; 1393-000841; 1393-000845; 1393-000847; 1393-000848; 1393-000849; 1393-000850; 1393-000851; 1393-000852; 1393-000853; 1393-000855; 1393-000856; 1393-000857; 1393-000858; 1393-000859; 1393-000860; 1393-000861; 1393-000862; 1393-000863; 1393-000864; 1393-000865; 1393-000866; 1393-000867; 1393-000868; 1393-000869; 1393-000870; 1393-000871; 1393-000872; 1393-000873; 1393-000874; 1393-000875; 1393-000876; 1393-000877; 1393-000878; 1393-000879; 1393-000880; 1393-000881; 1393-000882; 1393-000883; 1393-000884; 1393-000885; 1393-000886; 1393-000887; 1393-000888; 1393-000889; 1393-000890; 1393-000891; 1393-000892; 1393-000893; 1393-000894; 1393-000895; 1393-000896; 1393-000897; 1393-000898; 1393-000899; 1393-000900; 1393-000901; 1393-000902; 1393-000903; 1393-000905; 1393-000906; 1393-000907; 1393-000908; 1393-000909; 1393-000910; 1393-000911; 1393-000912; 1393-000913; 1393-000914; 1393-000915; 1393-000916; 1393-000917; 1393-000918; 1393-000919; 1393-000920; 1393-000921; 1393-000922; 1393-000923; 1393-000924; 1393-000925; 1393-000926; 1393-000927; 1393-000928; 1393-000929; 1393-000930; 1393-000931; 1393-000932; 1393-000933; 1393-000934; 1393-000935; 1393-000936; 1393-000937; 1393-000938; 1393-000939; 1393-000940; 1393-000941; 1393-000942; 1393-000943; 1393-000944; 1393-000945; 1393-000946; 1393-000947; 1393-000948; 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  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA