CLASS I ONGOING Device recall · Reported 28 Jul 2021 · FDA Enforcement Report

Philips Respironics V60 Plus Ventilator recalled

Respironics California is recalling Philips Respironics V60 Plus Ventilator, distributed nationwide in the US. The recall was initiated on 18 Jun 2021 and the FDA has classified it as Class I.

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Lot, batch or date codesModel 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; 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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 recalledTotal of V60/V60 Plus = 23,115 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2074-2021
FDA event ID: 88127
Recalling firm: Respironics California, Carlsbad, CA
Classification: Class I
Status: Ongoing
Recall initiated: 18 Jun 2021
FDA classified: 21 Jul 2021
Reported: 28 Jul 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: CPAP & Ventilators

Timeline

18 Jun 2021	Recall initiated by company
21 Jul 2021	Classified by FDA	+33 days
28 Jul 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Stores named: Target

Questions about this recall

Why was it recalled?

Which lots are affected?

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; 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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; 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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/ ;

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 88127

Reported	Class	Recall	Company	Reason	Where
28 Jul 2021	CLASS I	Philips Respironics V60 Ventilator recalled by Respironics California	Respironics California	Device Malfunction	Nationwide

More recalls from Respironics California

All 45

Reported	Class	Recall	Company	Reason	Where
27 Apr 2022Device	CLASS I	Philips Respironics V60 Ventilator (All recalled	Respironics California	Other	Nationwide
27 Apr 2022Device	CLASS I	Philips Respironics V60 Plus Ventilator (All recalled	Respironics California	Other	Nationwide
27 Apr 2022Device	CLASS I	Philips Respironics V680 Ventilator (All recalled	Respironics California	Other	Nationwide
9 Mar 2022Device	CLASS I	Philips Respironics V60 Ventilator recalled by Respironics California	Respironics California	Device Malfunction	13 states
9 Mar 2022Device	CLASS I	Philips Respironics V60 Plus Ventilator recalled	Respironics California	Device Malfunction	13 states

Other CPAP & Ventilators recalls

All 556

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Multiple-type respiratory pathogen nucleic acid IVD, kit recalled	BioFire Diagnostics	Device Malfunction	Nationwide
21 Oct 2026Device	CLASS II	Multiple-type respiratory pathogen nucleic acid IVD, kit recalled	BioFire Diagnostics	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS I	Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled	CooperSurgical	Other	Nationwide
30 Sep 2026Device	CLASS I	Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled	CooperSurgical	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled	Medline Industries	Device Malfunction	Nationwide