Events

Rappel de Device Recall Model 91393, Xprezzon Bedside Monitor

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Spacelabs Healthcare, Llc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    61919
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1705-2012
  • Date de mise en oeuvre de l'événement
    2012-05-22
  • Date de publication de l'événement
    2012-06-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-05-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109489
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Cause
    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.
  • 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.

Device

Device Recall Model 91393, Xprezzon Bedside Monitor
  • Modèle / numéro de série
    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; 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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.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • 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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Société-mère du fabricant (2017)
    OSI Systems Inc
  • Source
    USFDA