Events

Retiro De Equipo (Recall) de Device Recall Model 91393, Xprezzon Bedside Monitor

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Spacelabs Healthcare, Llc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    61919
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1705-2012
  • Fecha de inicio del evento
    2012-05-22
  • Fecha de publicación del evento
    2012-06-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-05-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109489
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Causa
    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.
  • Acción
    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.

Device

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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1393-001110; 1393-001111; 1393-001112; 1393-001113; 1393-001115; 1393-001116; 1393-001117; 1393-001118; 1393-001119; 1393-001120; 1393-001121; 1393-001122; 1393-001123; 1393-001124; 1393-001125; 1393-001126; 1393-001127; 1393-001128; 1393-001129; 1393-001130; 1393-001131; 1393-001132; 1393-001133; 1393-001134; 1393-001135; 1393-001136; 1393-001137; 1393-001138; 1393-001139; 1393-001140; 1393-001141; 1393-001142; 1393-001143; 1393-001144; 1393-001145; 1393-001146; 1393-001147; 1393-001148; 1393-001149; 1393-001150; 1393-001151; 1393-001152; 1393-001153; 1393-001154; 1393-001155; 1393-001156; 1393-001157; 1393-001158; 1393-001159; 1393-001160; 1393-001161; 1393-001162; 1393-001163; 1393-001164; 1393-001165; 1393-001166; 1393-001167; 1393-001168; 1393-001169; 1393-001170; 1393-001171; 1393-001172; 1393-001173; 1393-001174; 1393-001175; 1393-001176; 1393-001177; 1393-001178; 1393-001179; 1393-001180; 1393-001181; 1393-001182; 1393-001183; 1393-001184; 1393-001225; 1393-001226; 1393-001227; 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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.
  • Clasificación del producto
    Cardiovascular Devices
  • 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
    Spacelabs Healthcare, Llc

Manufacturer

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