Respironics California, LLC Recall 88127
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.
Respironics California, LLC Recall 88127 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2074-2021 |
| Event ID | 88127 |
| Event 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. |
| Product Type | Devices |
| 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. |
| Quantity | Total of V60/V60 Plus = 23,115 systems |
| Recall Reason | 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 Classification | 20210728 |
| Device Code Info | 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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HU2000449/ (01)00884838089280(21)HU2000449; HU2000459/ ; HU2000527/ ; HU2000574/ ; HU2000602/ ; HU2000667/ ; HU2000706/ ; HU2000865/ ; |
| Center Classification Date | 20210721 |
| Recall Initiation Date | 20210618 |
| Recalling Firm | Respironics California, LLC |
| Initial Notification | Letter |
| Similar To |