510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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Z-2074-2021Class I

Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus...

Respironics, Inc. / initiated 2021-06-18 / Open, Classified / root cause: design
FDA source (opens on fda.gov)

Respironics California, LLC began a recall of 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... on . FDA classified it as Class I and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number
Z-2074-2021
Classification
Class I
Status
Open, Classified
Initiated
Posted
Recalling firm
Respironics, Inc.
Product
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 code
MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
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.
Root cause tag
design
FDA root cause
Device Design
Action
On 06/18/2021, the Recalling Firm sent an "URGENT - Medical Device Recall" Notification Letter via USPS certified mail to customers informing them that a problem has been detected in their ventilators that could pose a risk to patients or users. All units with High Flow Therapy option (Software Versions 3.00 and 3.10) are impacted. These ventilators with the High Flow Therapy software were designed with a safety mechanism to limit the amount of pressure that can be delivered to the patient when the ventilator is operating in High Flow Therapy. In situations where the high flow therapy pressure reaches the maximum limit, the ventilator will sound a low priority "Cannot Reach Target Flow (CRTF) alarm and reduces the pressure which also simultaneously decreases the flow rate to a level below what was set by the clinician for as long as the condition persists. Customers are instructed/informed to: When administering HFT via High Flow Nasal Cannula the following action must be taken: (1) Monitor the patients SpO2 continuously; (2) All patients that are dependent on supplemental oxygen, and at risk of clinical deterioration should be under constant and close monitoring by the clinician to prevent dangerous drops in blood oxygen levels, work of breathing and respiratory distress and resulting escalation in medical treatment (3) Respond to all alarms urgently, regardless of alarm priority; (4) If the patient cannot be constantly and closely monitored by the clinician, do not use High Flow Therapy. In addition; (5) Refer to and follow the attached user manual addendum titled V60 Plus User Manual Addendum: High-Flow Therapy Safety and Alarm Features. This user manual addendum provides additional technical details about the CRTF alarm functionality. The addendum is also available at www.philips.com/hrcmanuals under the V60/V60 Plus link titled "V60 Plus User Manual Addendum - High-Flow Therapy Safety and Alarm Features. For additional information and educ
Quantity in commerce
Total of V60/V60 Plus = 23,115 systems
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.
Product codes and lots
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/ 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(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/ ;

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2074-2021
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2073-2021Class IOngoingVoluntary: Firm initiated
Z-2074-2021Class IOngoingVoluntary: Firm initiated