CLASS II Device recall · Reported 3 Feb 2021 · FDA Enforcement Report
Philips Respironics V60 Ventilator recalled by Respironics California
Respironics California is recalling Philips Respironics V60 Ventilator, distributed nationwide in the US. The recall was initiated on 30 Oct 2020 and the FDA has classified it as Class II.
Check your package
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-0900-2021
- FDA event ID
- 86646
- Recalling firm
- Respironics California, Carlsbad, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Oct 2020
- FDA classified
- 22 Jan 2021
- Reported
- 3 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 30 Oct 2020 | Recall initiated by company | |
| 22 Jan 2021 | Classified by FDA | +84 days |
| 3 Feb 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
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 Ventilator Part Number U1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Where it was distributed
Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE,NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Afghanistan, Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, French Guiana, French Polynesia, Germany, Ghana, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libya, Luxembourg, Malaysia, Maldives, Mali, Malta, Mexico, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, ST. Pier Miquel, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, Wallis Futuna, and Zambia.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Which lots are affected?
Model: V60 Ventilator, Part Number U1053617 V60 Ventilator, USED ENGL OPT:CFLEX, AVAPS,PPV,AT+ Serial Numbers: 100260233 100269324 100259732 100259863 100012867 100013831 100019589 100025024 100025938 100026001 100026663 100027660 100027968 100030595 100037381 100042754 100049903 100057035 100062238 100063161 100065043 100065047 100072563 100073252 100073254 100074566 100075395 100075396 100075409 100076087 100078252 100078850 100079007 100081754 100082656 100084977 100088335 100090937 100092047 100092057 100092309 100092442 100092544 100092969 100093791 100094690 100094731 100097992 100098699 100099976 100100750 100100856 100101065 100101404 100101408 100105454 100106192 100106406 100106521 100106590 100106715 100106884 100109744 100110298 100110378 100110458 100110478 100110479 100110485 100110489 100110598 100110610 100110673 100112876 100114470 100114525 100116572 100118818 100119210 100120753 100120821 100121402 100121456 100121686 100121815 100125763 100125926 100129587 100129595 100130458 100133611 100136136 100136643 100136655 100141903 100146850 100146852 100147180 100147797 100149576 100149714 100153310 100158909 100160567 100160569 100165175 100166344 100172321 100173098 100173451 100173878 100174081 100174140 100176545 100179474 100179478 100180773 100182557 100187312 100188343 100189912 100191275 100192793 100193226 100194905 100195660 100195872 100195875 100195889 100195891 100195892 100195899 100195968 100195969 100195970 100195978 100196000 100196002 100196004 100196005 100196006 100196007 100196008 100196010 100196012 100196013 100196015 100196016 100196017 100196018 100196019 100196020 100196021 100196022 100196100 100196101 100196103 100196104 100196106 100196107 100196108 100196109 100196110 100196111 100196112 100196113 100196114 100196115 100196117 100196118 100196119 100196120 100196121 100196122 100196123 100196124 100196125 100196126 100196128 100196129 100196130 100196131 100196132 100196134 100196135 100196136 100196137 100196139 100196400 100196401 100196403 100196406 100196407 100196408 100196409 100196410 100196411 100196413 100196414 100196415 100196416 100196417 100196418 100196419 100196420 100196421 100196422 100196423 100196424 100196425 100196426 100196427 100196428 100196434 100196619 100219464 100219967 100221176 100223855 100224350 100224708 100224970 100226526 100230373 100232632 100236034 100236968 100238071 100238136 100239821 100241846 100244859 100246583 100248301 100249178 100251889 100252101 100252951 100254743 100254960 100256421 100256849 100263569 100269325 100278293 100279592 100280589 201000762 201000769 201000770 201001941 201002494 201004093 201004394 201005787 201007765 201008139 201009340 201009889 201009948 201010587 201011021 201013041 201013786 201014044 201015018 201015057 201015083 201015127 201015481 201017700 201021042 201021044 201023087 201023345 201024350 201024382 201024385 201024483 201024747 201026183 201027175 201027359 201028921 201029423 201029806 201029966 201029975 201030285 201030856 201031934 201031987
Where was it sold?
Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE,NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Afghanistan, Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, French Guiana, French Polynesia, Germany, Ghana, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libya, Luxembourg, Malaysia, Maldives, Mali, Malta, Mexico, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, ST. Pier Miquel, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, Wallis Futuna, and Zambia.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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
13 other products · FDA event 86646This product is part of a recall event; the main page for the event is Philips Respironics V60 Ventilator recalled by Respironics California.
More recalls from Respironics California
All 45| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Philips Respironics V60 Ventilator (All recalled | Respironics California | Other | Nationwide |
| Device | CLASS I | Philips Respironics V60 Plus Ventilator (All recalled | Respironics California | Other | Nationwide |
| Device | CLASS I | Philips Respironics V680 Ventilator (All recalled | Respironics California | Other | Nationwide |
| Device | CLASS I | Philips Respironics V60 Ventilator recalled by Respironics California | Respironics California | Device Malfunction | 13 states |
| Device | CLASS I | Philips Respironics V60 Plus Ventilator recalled | Respironics California | Device Malfunction | 13 states |
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