Events

Device Recall Model 91393, Xprezzon Bedside Monitor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Spacelabs Healthcare, Llc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    61919
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1705-2012
  • 사례 시작날짜
    2012-05-22
  • 사례 출판 날짜
    2012-06-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-05-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109489
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • 원인
    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.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    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; 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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; 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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.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 제조사 주소
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • 제조사 모회사 (2017)
    OSI Systems Inc
  • Source
    USFDA