Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics ...
FDA Device Recall #Z-2074-2021 — Class I — June 18, 2021
Recall Summary
| Recall Number | Z-2074-2021 |
| Classification | Class I — Serious risk |
| Date Initiated | June 18, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Respironics California, LLC |
| Location | Carlsbad, CA |
| Product Type | Devices |
| Quantity | Total of V60/V60 Plus = 23,115 systems |
Product Description
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.
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.
Distribution Pattern
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.
Lot / Code Information
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/ ; 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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/ ;
Other Recalls from Respironics California, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0909-2022 | Class I | Philips Respironics V680 Ventilator (All Models... | Feb 28, 2022 |
| Z-0907-2022 | Class I | Philips Respironics V60 Ventilator (All Models,... | Feb 28, 2022 |
| Z-0908-2022 | Class I | Philips Respironics V60 Plus Ventilator (All Mo... | Feb 28, 2022 |
| Z-0662-2022 | Class I | Philips Respironics V60 Ventilator Part Number ... | Jan 24, 2022 |
| Z-0663-2022 | Class I | Philips Respironics V60 Plus Ventilator Part Nu... | Jan 24, 2022 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.