Spacelabs Healthcare, Llc: 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.

Recall number

Z-1705-2012

Recalling firm

Spacelabs Healthcare, Llc

Product

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.

Status

Terminated

Initiated

2012-05-22

Posted

2012-06-05

Terminated

2013-05-07

Reason

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.

Root cause

Device Design

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.

Quantity

1898 monitors (Domestic: 1188) (International: 710)

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.

Lot, serial or model codes

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; 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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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1393-000707; 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; 1393-000949; 1393-000950; 1393-000951; 1393-000952; 1393-000953; 1393-000954; 1393-000955; 1393-000956; 1393-000957; 1393-000958; 1393-000959; 1393-000960; 1393-000961; 1393-000962; 1393-000963; 1393-000964; 1393-000965; 1393-000966; 1393-000967; 1393-000971; 1393-000972; 1393-000973; 1393-000974; 1393-000975; 1393-000976; 1393-000977; 1393-000978; 1393-000979; 1393-000980; 1393-000981; 1393-000982; 1393-000983; 1393-000984; 1393-000985; 1393-000987; 1393-000988; 1393-000989; 1393-000990; 1393-000991; 1393-000992; 1393-000993; 1393-000994; 1393-000995; 1393-000996; 1393-000997; 1393-000998; 1393-000999; 1393-001000; 1393-001001; 1393-001002; 1393-001003; 1393-001004; 1393-001005; 1393-001006; 1393-001007; 1393-001008; 1393-001009; 1393-001010; 1393-001011; 1393-001012; 1393-001013; 1393-001014; 1393-001015; 1393-001016; 1393-001017; 1393-001018; 1393-001019; 1393-001020; 1393-001021; 1393-001022; 1393-001023; 1393-001024; 1393-001025; 1393-001026; 1393-001027; 1393-001028; 1393-001029; 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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.

510(k) numbers

["K112962"]

PMA numbers

not on file

Product code

MHX

Firm FEI

3010157426

Firm city

Issaquah

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy