FDA Device Recall Z-2074-2021

Device

Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.

Lot / serial / GTIN: Model V60 Plus Ventilator: P/N 1138747 and 1137276; US System Serial Number/UDI Code: 100363973/ ; 100366525/ ; 100366542/ ; 100371876/ (01)00884838090996(21)100371876; 100373102/ (01)00884838090996(21)100373102; 100374459/ (01)00884838090996(21)100374459; 100376350/ (01)00884838090996(21)100376350; 100377311/ (01)00884838090996(21)100377311; 100377324/ (01)00884838090996(21)100377324; 100380441/ (01)00884838090996(21)100380441; 100382407/ (01)00884838090996(21)100382407; 100382452/ (01)00884838090996(21)100382452; 100382461/ (01)00884838090996(21)100382461; 100384413/ (01)00884838090996(21)100384413; 100384748/ (01)00884838090996(21)100384748; 100385425/ (01)00884838090996(21)100385425; 100385428/ (01)00884838090996(21)100385428; 100385429/ (01)00884838090996(21)100385429; 100385447/ (01)00884838090996(21)100385447; 100385529/ (01)00884838090996(21)100385529; 100386081/ (01)00884838090996(21)100386081; 100386137/ (01)00884838090996(21)100386137; 100386179/ (01)00884838090996(21)100386179; 100389986/ (01)00884838090996(21)100389986; 100390076/ (01)00884838090996(21)100390076; 100392652/ (01)00884838090996(21)100392652; 100392801/ (01)00884838090996(21)100392801; 100392809/ (01)00884838090996(21)100392809; 100392899/ (01)00884838090996(21)100392899; 100393482/ (01)00884838090996(21)100393482; 100393544/ (01)00884838090996(21)100393544; 100393555/ (01)00884838090996(21)100393555; 100393571/ (01)00884838090996(21)100393571; 100393741/ (01)00884838090996(21)100393741; 100393749/ (01)00884838090996(21)100393749; 100395503/ (01)00884838090996(21)100395503; 100395807/ (01)00884838090996(21)100395807; 100396158/ (01)00884838090996(21)100396158; 100396540/ (01)00884838090996(21)100396540; 100396598/ (01)00884838090996(21)100396598; 100396747/ (01)00884838090996(21)100396747; 100398796/ (01)00884838090996(21)100398796; 100398852/ (01)00884838090996(21)100398852; 100403796/ (01)00884838090996(21)100403796; 100403798/ (01)00884838090996(21)100403798; 100403813/ (01)00884838090996(21)100403813; 100403828/ (01)00884838090996(21)100403828; 100403830/ (01)00884838090996(21)100403830; 100403832/ (01)00884838090996(21)100403832; 100403842/ (01)00884838090996(21)100403842; 100404111/ (01)00884838090996(21)100404111; 100404113/ (01)00884838090996(21)100404113; 100404114/ (01)00884838090996(21)100404114; 100404115/ (01)00884838090996(21)100404115; 100404117/ (01)00884838090996(21)100404117; 100404118/ (01)00884838090996(21)100404118; 100404124/ (01)00884838090996(21)100404124; 100404131/ (01)00884838090996(21)100404131; 100404192/ (01)00884838090996(21)100404192; 100405715/ (01)00884838090996(21)100405715; 100405718/ (01)00884838090996(21)100405718; 100405741/ (01)00884838090996(21)100405741; 100405742/ (01)00884838090996(21)100405742; 100406077/ (01)00884838090996(21)100406077; 100406208/ (01)00884838090996(21)100406208; 100408124/ (01)00884838090996(21)100408124; 100408126/ (01)00884838090996(21)100408126; 100408129/ (01)00884838090996(21)100408129; 100408133/ (01)00884838090996(21)100408133; 100408137/ (01)00884838090996(21)100408137; 100408144/ (01)00884838090996(21)100408144; 100408149/ (01)00884838090996(21)100408149; 100408419/ (01)00884838090996(21)100408419; 100408882/ (01)00884838090996(21)100408882; 100408886/ (01)00884838090996(21)100408886; 100408899/ (01)00884838090996(21)100408899; 100408901/ (01)00884838090996(21)100408901; 100409389/ (01)00884838090996(21)100409389; 100409394/ (01)00884838090996(21)100409394; 100409537/ (01)00884838090996(21)100409537; 100409560/ (01)00884838090996(21)100409560; 100409712/ (01)00884838090996(21)100409712; 100409734/ (01)00884838090996(21)100409734; 100409932/ (01)00884838090996(21)100409932; 100409937/ (01)00884838090996(21)100409937; 100410001/ (01)00884838090996(21)100410001; 100410024/ (01)00884838090996(21)100410024; 100412283/ (01)00884838090996(21)100412283; 100412293/ (01)00884838090996(21)100412293; 100412450/ (01)00884838090996(21)100412450; 100412596/ (01)00884838090996(21)100412596; 100412940/ (01)00884838090996(21)100412940; 100412943/ (01)00884838090996(21)100412943; 100412976/ (01)00884838090996(21)100412976; 100412980/ (01)00884838090996(21)100412980; 100412981/ (01)00884838090996(21)100412981; 100413021/ (01)00884838090996(21)100413021; 100413027/ (01)00884838090996(21)100413027; 100413028/ (01)00884838090996(21)100413028; 100413030/ (01)00884838090996(21)100413030; 100413033/ (01)00884838090996(21)100413033; 100413524/ (01)00884838090996(21)100413524; 100413571/ (01)00884838090996(21)100413571; 100413663/ (01)00884838090996(21)100413663; 100413670/ (01)00884838090996(21)100413670; 100413672/ (01)00884838090996(21)100413672; 100413837/ (01)00884838090996(21)100413837; 100413905/ (01)00884838090996(21)100413905; 100413990/ (01)00884838090996(21)100413990; 100414030/ (01)00884838090996(21)100414030; 100414034/ (01)00884838090996(21)100414034; 100414256/ (01)00884838090996(21)100414256; 100414346/ (01)00884838090996(21)100414346; 100414349/ (01)00884838090996(21)100414349; 100414484/ (01)00884838090996(21)100414484; 100414490/ (01)00884838090996(21)100414490; 100414496/ (01)00884838090996(21)100414496; 100414498/ (01)00884838090996(21)100414498; 100414503/ (01)00884838090996(21)100414503; 100414510/ (01)00884838090996(21)100414510; 100414527/ (01)00884838090996(21)100414527; 100414530/ (01)00884838090996(21)100414530; 100415081/ (01)00884838090996(21)100415081; 100415124/ (01)00884838090996(21)100415124; 100416665/ (01)00884838090996(21)100416665; 100416680/ (01)00884838090996(21)100416680; 100416717/ (01)00884838090996(21)100416717; 100417376/ (01)00884838090996(21)100417376; 100417558/ (01)00884838090996(21)100417558; 100417661/ (01)00884838090996(21)100417661; 100417668/ (01)00884838090996(21)100417668; 100417684/ (01)00884838090996(21)100417684; 100417892/ (01)00884838090996(21)100417892; 100418072/ (01)00884838090996(21)100418072; 100418075/ (01)00884838090996(21)100418075; 100418093/ (01)00884838090996(21)100418093; 100418094/ (01)00884838090996(21)100418094; 100418494/ (01)00884838090996(21)100418494; 100418618/ (01)00884838090996(21)100418618; 100419145/ (01)00884838090996(21)100419145; 100419163/ (01)00884838090996(21)100419163; 100419962/ (01)00884838090996(21)100419962; 100419968/ (01)00884838090996(21)100419968; 100419976/ (01)00884838090996(21)100419976; 100420066/ (01)00884838090996(21)100420066; 100420219/ (01)00884838090996(21)100420219; 100420305/ (01)00884838090996(21)100420305; 100420315/ (01)00884838090996(21)100420315; 100420989/ (01)00884838090996(21)100420989; 100420990/ (01)00884838090996(21)100420990; 100421014/ (01)00884838090996(21)100421014; 100421320/ (01)00884838090996(21)100421320; 100421554/ (01)00884838090996(21)100421554; 100421861/ (01)00884838090996(21)100421861; 100422301/ (01)00884838090996(21)100422301; 100422313/ (01)00884838090996(21)100422313; 100423017/ (01)00884838090996(21)100423017; 100423029/ (01)00884838090996(21)100423029; 100423344/ ; 100423346/ (01)00884838090996(21)100423346; 100423348/ ; 100423352/ (01)00884838090996(21)100423352; 100423551/ (01)00884838090996(21)100423551; 100423558/ (01)00884838090996(21)100423558; 100423682/ (01)00884838090996(21)100423682; 100423683/ ; 100423685/ (01)00884838090996(21)100423685; 100423814/ (01)00884838090996(21)100423814; 100423846/ (01)00884838090996(21)100423846; 100423851/ (01)00884838090996(21)100423851; 100423877/ (01)00884838090996(21)100423877; 100423906/ (01)00884838090996(21)100423906; 100423924/ (01)00884838090996(21)100423924; 100423930/ (01)00884838090996(21)100423930; 100423934/ (01)00884838090996(21)100423934; 100424157/ (01)00884838090996(21)100424157; 100424778/ (01)00884838090996(21)100424778; 100425150/ (01)00884838090996(21)100425150; 100425183/ (01)00884838090996(21)100425183; 100425226/ (01)00884838090996(21)100425226; 100425229/ ; 100425230/ (01)00884838090996(21)100425230; 100425235/ (01)00884838090996(21)100425235; 100425696/ ; 100425742/ (01)00884838090996(21)100425742; 100427796/ (01)00884838090996(21)100427796; 100427967/ ; 100428999/ (01)00884838090996(21)100428999; 100429553/ (01)00884838090996(21)100429553; 100429568/ (01)00884838090996(21)100429568; 100431103/ ; 100431133/ (01)00884838090996(21)100431133; 100431231/ (01)00884838090996(21)100431231; 100431316/ (01)00884838090996(21)100431316; 100431449/ ; 100431724/ (01)00884838090996(21)100431724; 100431755/ ; 100431756/ ; 100432709/ ; 100432710/ ; 100433807/ ; 100433814/ ; 100433815/ (01)00884838090996(21)100433815; 100433817/ (01)00884838090996(21)100433817; 100433827/ (01)00884838090996(21)100433827; 100433837/ (01)00884838090996(21)100433837; 100433901/ ; 100433903/ ; 100433909/ (01)00884838090996(21)100433909; 100433910/ ; 100433911/ (01)00884838090996(21)100433911; 100434067/ (01)00884838090996(21)100434067; 100434069/ ; 100434077/ ; 100434078/ (01)00884838090996(21)100434078; 100434180/ (01)00884838090996(21)100434180; 100434185/ ; 100434197/ (01)00884838090996(21)100434197; 100435673/ (01)00884838089280(21)100435673; 100436278/ (01)00884838090996(21)100436278; 100436322/ (01)00884838090996(21)100436322; 100436598/ (01)00884838090996(21)100436598; 100436641/ (01)00884838090996(21)100436641; 100436649/ (01)00884838090996(21)100436649; 100436654/ (01)00884838090996(21)100436654; 100436661/ ; 100436680/ (01)00884838090996(21)100436680; 100436685/ (01)00884838090996(21)100436685; 100436691/ (01)00884838090996(21)100436691; 100436696/ (01)00884838090996(21)100436696; 100436700/ (01)00884838090996(21)100436700; 100436799/ (01)00884838090996(21)100436799; 100436809/ (01)00884838090996(21)100436809; 100437253/ (01)00884838090996(21)100437253; 100437269/ (01)00884838090996(21)100437269; 100447800/ (01)00884838090996(21)100447800; 100447802/ (01)00884838090996(21)100447802; 100447803/ (01)00884838090996(21)100447803; 100447807/ (01)00884838090996(21)100447807; 100447817/ (01)00884838090996(21)100447817; 100448385/ (01)00884838090996(21)100448385; 100448386/ (01)00884838090996(21)100448386; 100448501/ (01)00884838090996(21)100448501; 100448509/ (01)00884838090996(21)100448509; 100448516/ (01)00884838090996(21)100448516; 100448519/ (01)00884838090996(21)100448519; 100448563/ (01)00884838090996(21)100448563; 100448570/ (01)00884838090996(21)100448570; 100448572/ (01)00884838090996(21)100448572; 100448587/ (01)00884838090996(21)100448587; 100448588/ (01)00884838090996(21)100448588; 100448729/ (01)00884838090996(21)100448729; 100448730/ (01)00884838090996(21)100448730; 100448733/ (01)00884838090996(21)100448733; 100455183/ (01)00884838090996(21)100455183; 100458043/ (01)00884838090996(21)100458043; 100458826/ (01)00884838090996(21)100458826; MX0000539/ (01)00884838090996(21)MX0000539; MX0000558/ (01)00884838090996(21)MX0000558; MX0001763/ (01)00884838090996(21)MX0001763; MX0002491/ (01)00884838090996(21)MX0002491; MX0002704/ (01)00884838090996(21)MX0002704; MX0002716/ (01)00884838090996(21)MX0002716; MX0002723/ (01)00884838090996(21)MX0002723; MX0002728/ (01)00884838090996(21)MX0002728; MX0002731/ (01)00884838090996(21)MX0002731; MX0002737/ (01)00884838090996(21)MX0002737; MX0002751/ (01)00884838090996(21)MX0002751; MX0002761/ (01)00884838090996(21)MX0002761; MX0002764/ (01)00884838090996(21)MX0002764; MX0002768/ (01)00884838090996(21)MX0002768; MX0002819/ (01)00884838090996(21)MX0002819; MX0003003/ (01)00884838090996(21)MX0003003; MX0003012/ (01)00884838090996(21)MX0003012; MX0003460/ (01)00884838090996(21)MX0003460; MX0003474/ (01)00884838090996(21)MX0003474; MX0003496/ (01)00884838090996(21)MX0003496; MX0003503/ (01)00884838090996(21)MX0003503; MX0003505/ (01)00884838090996(21)MX0003505; MX0003546/ (01)00884838090996(21)MX0003546; MX0003555/ (01)00884838090996(21)MX0003555; MX0004467/ (01)00884838090996(21)MX0004467; MX0004469/ (01)00884838090996(21)MX0004469; MX0004470/ (01)00884838090996(21)MX0004470; MX0007172/ (01)00884838090996(21)MX0007172; MX0007173/ (01)00884838090996(21)MX0007173; MX0007179/ (01)00884838090996(21)MX0007179; MX0007198/ ; MX0007230/ (01)00884838090996(21)MX0007230; MX0007242/ (01)00884838090996(21)MX0007242; MX0007243/ (01)00884838090996(21)MX0007243; MX0007253/ (01)00884838090996(21)MX0007253; MX0007538/ (01)00884838090996(21)MX0007538; MX0007541/ (01)00884838090996(21)MX0007541; MX0007542/ (01)00884838090996(21)MX0007542; MX0007577/ (01)00884838090996(21)MX0007577; MX0007585/ ; MX0007587/ (01)00884838090996(21)MX0007587; MX0007592/ (01)00884838090996(21)MX0007592; MX0007606/ (01)00884838090996(21)MX0007606; MX0007837/ (01)00884838090996(21)MX0007837; MX0007860/ (01)00884838090996(21)MX0007860; MX0008995/ (01)00884838090996(21)MX0008995; MX0009104/ (01)00884838090996(21)MX0009104; MX0009145/ (01)00884838090996(21)MX0009145; MX0009758/ (01)00884838090996(21)MX0009758; MX0010728/ (01)00884838090996(21)MX0010728; MX0010733/ (01)00884838090996(21)MX0010733; MX0010735/ (01)00884838090996(21)MX0010735; MX0011083/ (01)00884838090996(21)MX0011083; MX0013445/ (01)00884838090996(21)MX0013445; MX0013515/ (01)00884838090996(21)MX0013515; MX0015091/ ; MX0015092/ (01)00884838090996(21)MX0015092; MX0015099/ (01)00884838090996(21)MX0015099; MX0015110/ (01)00884838090996(21)MX0015110; MX0015123/ (01)00884838090996(21)MX0015123; MX0015124/ (01)00884838090996(21)MX0015124; MX0015130/ ; MX0015144/ (01)00884838090996(21)MX0015144; MX0015146/ (01)00884838090996(21)MX0015146; MX0015158/ (01)00884838090996(21)MX0015158; MX0015168/ (01)00884838090996(21)MX0015168; MX0015172/ (01)00884838090996(21)MX0015172; MX0015469/ (01)00884838090996(21)MX0015469; 100436648/ (01)00884838090996(21)100436648; 100436324/ (01)00884838090996(21)100436324; OUS(International) System Serial Number/UDI Code: 100280989/ ; 100282854/ ; 100289689/ ; 100289695/ ; 100289696/ ; 100289709/ ; 100290610/ ; 100290613/ ; 100290614/ ; 100290616/ ; 100290648/ ; 100290654/ ; 100290664/ ; 100291847/ ; 100292342/ ; 100296023/ ; 100297858/ ; 100297860/ ; 100298767/ ; 100298928/ ; 100302008/ ; 100302015/ ; 100302023/ ; 100302027/ ; 100302260/ ; 100304762/ ; 100304779/ ; 100305136/ ; 100305439/ ; 100305742/ ; 100305743/ ; 100305745/ ; 100305746/ ; 100305747/ ; 100305831/ ; 100306474/ ; 100309481/ ; 100309494/ ; 100309574/ ; 100309640/ ; 100309643/ ; 100309645/ ; 100309735/ ; 100311163/ (01)00884838089280(21)100311163; 100311175/ ; 100314682/ ; 100314684/ ; 100314877/ ; 100315149/ ; 100315152/ ; 100315157/ ; 100315614/ ; 100315897/ ; 100318607/ ; 100318610/ ; 100318612/ ; 100318614/ ; 100319291/ ; 100319302/ ; 100319775/ ; 100319777/ ; 100320373/ ; 100320645/ ; 100321730/ ; 100321910/ ; 100321913/ ; 100322636/ ; 100322640/ ; 100322876/ ; 100322898/ ; 100322903/ ; 100325105/ ; 100325106/ ; 100325107/ ; 100325111/ ; 100325113/ ; 100325116/ ; 100327540/ ; 100327544/ ; 100335583/ ; 100336136/ ; 100336757/ ; 100336758/ ; 100336902/ ; 100337081/ ; 100337087/ ; 100337093/ ; 100337263/ ; 100338949/ ; 100338950/ ; 100338953/ ; 100339023/ ; 100339027/ ; 100339232/ (01)00884838089280(21)100339232; 100339234/ (01)00884838089280(21)100339234; 100339236/ ; 100339246/ ; 100339315/ ; 100339317/ ; 100339324/ ; 100339497/ (01)00884838089280(21)100339497; 100340912/ ; 100341120/ ; 100341166/ ; 100341191/ ; 100341366/ ; 100341397/ ; 100341866/ ; 100341882/ ; 100341890/ ; 100341908/ ; 100341909/ ; 100341910/ ; 100341999/ ; 100342525/ ; 100342534/ ; 100342536/ ; 100342539/ ; 100342545/ ; 100342547/ ; 100342548/ ; 100342559/ ; 100342561/ ; 100342565/ ; 100342566/ ; 100342571/ ; 100342579/ ; 100342890/ ; 100342896/ ; 100342897/ ; 100342935/ ; 100342942/ ; 100342943/ ; 100342947/ ; 100342950/ ; 100342968/ ; 100342977/ ; 100342978/ ; 100342979/ ; 100342983/ ; 100343100/ ; 100343103/ ; 100343104/ ; 100343105/ ; 100343112/ ; 100343113/ ; 100343124/ ; 100343128/ ; 100343131/ ; 100343138/ ; 100343142/ ; 100343153/ ; 100343160/ ; 100343569/ ; 100343622/ ; 100343628/ (01)00884838089280(21)100343628; 100343681/ ; 100344206/ ; 100344207/ ; 100344210/ ; 100344653/ ; 100344655/ ; 100344663/ ; 100344665/ ; 100344667/ ; 100344681/ ; 100344685/ ; 100344687/ ; 100344697/ ; 100344859/ ; 100345114/ ; 100345116/ ; 100345127/ ; 100345130/ ; 100345132/ ; 100345141/ ; 100345326/ ; 100345518/ ; 100345564/ ; 100345588/ ; 100345617/ ; 100346214/ ; 100346215/ ; 100346216/ ; 100346219/ ; 100346242/ ; 100346246/ ; 100346253/ ; 100346256/ ; 100346288/ ; 100346290/ ; 100346292/ ; 100346293/ ; 100346299/ ; 100346322/ ; 100346329/ ; 100346849/ ; 100346854/ ; 100346856/ ; 100346858/ ; 100346878/ ; 100346912/ ; 100348113/ ; 100348130/ ; 100348138/ ; 100348149/ ; 100348173/ ; 100348175/ ; 100348442/ ; 100348447/ ; 100350134/ ; 100350669/ ; 100350677/ ; 100350712/ ; 100350715/ ; 100350903/ ; 100351553/ ; 100351557/ ; 100351559/ ; 100351560/ ; 100351561/ ; 100351569/ ; 100351574/ ; 100351581/ ; 100351587/ ; 100351708/ ; 100351709/ ; 100351716/ ; 100351723/ ; 100352069/ ; 100352090/ ; 100352099/ ; 100352100/ ; 100352106/ ; 100352117/ ; 100352136/ ; 100352745/ ; 100352752/ ; 100352781/ ; 100352801/ ; 100352810/ ; 100352815/ ; 100353244/ ; 100353254/ ; 100353271/ ; 100353280/ ; 100353288/ (01)00884838089280(21)100353288; 100353589/ ; 100354439/ ; 100354471/ ; 100354475/ ; 100354705/ (01)00884838089280(21)100354705; 100355164/ (01)00884838089280(21)100355164; 100355673/ ; 100355856/ ; 100355896/ ; 100357138/ ; 100357735/ ; 100357777/ ; 100358173/ ; 100358181/ ; 100358197/ ; 100358349/ ; 100359518/ ; 100359519/ ; 100359609/ ; 100359617/ (01)00884838089280(21)100359617; 100359645/ ; 100359647/ ; 100359870/ ; 100359873/ ; 100360147/ ; 100360213/ ; 100360371/ ; 100361205/ ; 100361424/ ; 100361429/ ; 100361504/ ; 100361578/ ; 100361585/ ; 100361766/ ; 100361768/ ; 100361963/ ; 100361973/ ; 100362515/ ; 100363001/ ; 100363012/ ; 100363014/ ; 100363021/ ; 100363026/ ; 100363042/ ; 100363719/ ; 100363771/ ; 100363781/ ; 100364568/ ; 100364600/ ; 100365160/ ; 100365172/ ; 100367184/ ; 100367279/ ; 100368019/ ; 100368075/ ; 100368622/ ; 100369687/ ; 100369690/ ; 100369698/ ; 100369719/ ; 100369908/ ; 100370031/ ; 100371204/ ; 100375137/ ; 100375327/ ; 100375328/ ; 100375337/ ; 100375412/ ; 100375444/ (01)00884838089280(21)100375444; 100375448/ ; 100375456/ ; 100375460/ ; 100375478/ ; 100375479/ ; 100376361/ (01)00884838089280(21)100376361; 100376366/ (01)00884838089280(21)100376366; 100378646/ (01)00884838089280(21)100378646; 100378659/ ; 100380816/ (01)00884838089280(21)100380816; 100381005/ (01)00884838089280(21)100381005; 100381265/ ; 100381339/ (01)00884838089280(21)100381339; 100381857/ (01)00884838089280(21)100381857; 100383292/ (01)00884838089280(21)100383292; 100384081/ (01)00884838089280(21)100384081; 100384771/ (01)00884838089280(21)100384771; 100384773/ (01)00884838089280(21)100384773; 100384806/ (01)00884838089280(21)100384806; 100385304/ (01)00884838089280(21)100385304; 100385342/ (01)00884838089280(21)100385342; 100385359/ (01)00884838089280(21)100385359; 100387277/ (01)00884838089280(21)100387277; 100387296/ (01)00884838089280(21)100387296; 100387308/ (01)00884838089280(21)100387308; 100387830/ (01)00884838089280(21)100387830; 100387874/ (01)00884838089280(21)100387874; 100387885/ (01)00884838089280(21)100387885; 100389427/ (01)00884838089280(21)100389427; 100390083/ (01)00884838089280(21)100390083; 100390089/ (01)00884838089280(21)100390089; 100391984/ (01)00884838089280(21)100391984; 100392618/ (01)00884838089280(21)100392618; 100392632/ (01)00884838089280(21)100392632; 100395357/ (01)00884838089280(21)100395357; 100399025/ (01)00884838089280(21)100399025; 100399325/ ; 100399414/ ; 100400107/ (01)00884838089280(21)100400107; 100400420/ (01)00884838089280(21)100400420; 100400924/ ; 100400929/ ; 100401134/ (01)00884838089280(21)100401134; 100401137/ ; 100402491/ ; 100402502/ (01)00884838089280(21)100402502; 100402955/ ; 100403074/ (01)00884838089280(21)100403074; 100404141/ (01)00884838089280(21)100404141; 100411608/ ; 100411615/ (01)00884838089280(21)100411615; 100426463/ (01)00884838089280(21)100426463; 100426923/ (01)00884838089280(21)100426923; 100434598/ ; 100438752/ ; 100440475/ (01)00884838089280(21)100440475; 100440835/ ; 100446264/ (01)00884838089280(21)100446264; 100456002/ (01)00884838089280(21)100456002; 201035973/ ; 201036161/ ; 201036162/ ; 201036163/ ; 201036171/ ; 201036175/ ; 201036177/ ; 201036179/ ; 201036180/ ; 201036256/ ; 201036259/ ; 201036272/ ; 201036274/ ; 201038686/ ; 201040131/ ; 201040182/ ; 201040188/ ; 201040197/ ; 201040198/ ; 201040199/ ; 201040210/ ; 201040337/ ; 201040368/ ; 201040464/ ; 201040465/ ; 201040480/ ; 201040556/ ; 201040583/ ; 201040589/ ; 201040594/ ; 201040604/ ; 201040624/ ; 201040628/ ; 201040647/ ; HU2000081/ (01)00884838089280(21)HU2000081; HU2000084/ (01)00884838089280(21)HU2000084; HU2000086/ (01)00884838089280(21)HU2000086; HU2000091/ (01)00884838089280(21)HU2000091; HU2000092/ (01)00884838089280(21)HU2000092; HU2000106/ (01)00884838089280(21)HU2000106; HU2000108/ (01)00884838089280(21)HU2000108; HU2000127/ (01)00884838089280(21)HU2000127; HU2000131/ (01)00884838089280(21)HU2000131; HU2000136/ (01)00884838089280(21)HU2000136; HU2000155/ (01)00884838089280(21)HU2000155; HU2000172/ (01)00884838089280(21)HU2000172; HU2000201/ (01)00884838089280(21)HU2000201; HU2000217/ ; HU2000279/ (01)00884838089280(21)HU2000279; HU2000309/ ; HU2000324/ (01)00884838089280(21)HU2000324; HU2000393/ (01)00884838089280(21)HU2000393; HU2000427/ (01)00884838089280(21)HU2000427; HU2000449/ (01)00884838089280(21)HU2000449; HU2000459/ ; HU2000527/ ; HU2000574/ ; HU2000602/ ; HU2000667/ ; HU2000706/ ; HU2000865/ ;

Quantity: Total of V60/V60 Plus = 23,115 systems

Reason for recall

It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the "Cannot Reach Target Flow" alarm , the system will reduce pressure and simultaneously decreasing the flow rate to a level below what was set by the clinicians. If the reason for the increase in pressure is not resolved, the ventilator will continue to provide the lower flow rate, which result in patients experiencing oxygen desaturation which can be characterized as moderate or severe hypoxemia.

Recall record

Recall number

Z-2074-2021

Classification

Class I

Status

Ongoing

Voluntary or mandated

Voluntary: Firm initiated

Firm notification

Letter

Distribution

Worldwide Distribution: U.S (nationwide) to states of.: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and O.U.S. countries of: Andorra, United Arab Emirates, Albania, Argentina, Austria, Australia, Belgium, Canada, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, French Guiana, Guadeloupe, Greece, Hong Kong, Indonesia, Ireland, India, Iceland, Italy, Jordan, Kenya, Kuwait, Lebanon, Latvia, Libya, Morocco, Martinique, Malta, Mexico, Malaysia, New Caledonia, Nigeria, Netherlands, Norway, New Zealand, Philippines, Poland, Portugal, Qatar, R¿union, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, and South Africa.

Recall initiated

2021-06-18

Classified by FDA Center

2021-07-21

FDA published

2021-07-28

Recalling firm

Respironics California, LLC

Firm location

Carlsbad, CA