CLASS I ONGOING Device recall · Reported 27 Apr 2022 · FDA Enforcement Report

Philips Respironics V680 Ventilator (All recalled

Respironics California is recalling Philips Respironics V680 Ventilator (All, distributed nationwide in the US. The recall was initiated on 28 Feb 2022 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll Lots & Serial Numbers ; *Distributed outside the Untied States

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-0909-2022
FDA event ID: 89767
Recalling firm: Respironics California, Carlsbad, CA
Classification: Class I
Status: Ongoing
Recall initiated: 28 Feb 2022
FDA classified: 18 Apr 2022
Reported: 27 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

28 Feb 2022	Recall initiated by company
18 Apr 2022	Classified by FDA	+49 days
27 Apr 2022	Published in enforcement report	+9 days

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

Reason for recall

Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.

Product as listed by the FDA

Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States

Where it was distributed

Worldwide distribution US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Afghanistan, Albania, Algeria, American Samoa, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Comoros, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, French Guiana, French Polynesia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Luxembourg, Malaysia, Maldives, Mali, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland , Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, St. Pier, Miquel., Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Ukraine, United Kingdom, Utd. Arab. Emir., Venezuela, Vietnam, Wallis, Futuna, Zambia, Japan.

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

Questions about this recall

Why was it recalled?

Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.

Which lots are affected?

All Lots & Serial Numbers ; *Distributed outside the Untied States

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

2 other products · FDA event 89767

Reported	Class	Recall	Company	Reason	Where
27 Apr 2022	CLASS I	Philips Respironics V60 Plus Ventilator (All recalled	Respironics California	Other	Nationwide
27 Apr 2022	CLASS I	Philips Respironics V60 Ventilator (All recalled	Respironics California	Other	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
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
28 Jul 2021Device	CLASS I	Philips Respironics V60 Ventilator recalled by Respironics California	Respironics California	Device Malfunction	Nationwide

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