CLASS II ONGOING 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 2 Nov 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: V60 Part Number: R1053618 V60 Ventilator, Japan Opt: CFLEX,AVAPS Serial Numbers: 100039155 100054624 100054738

Quantity recalled3 systems

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-0909-2021
FDA event ID: 86697
Recalling firm: Respironics California, Carlsbad, CA
Classification: Class II
Status: Ongoing
Recall initiated: 2 Nov 2020
FDA classified: 22 Jan 2021
Reported: 3 Feb 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

2 Nov 2020	Recall initiated by company
22 Jan 2021	Classified by FDA	+81 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

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

Product as listed by the FDA

Philips Respironics V60 Ventilator Part Number R1053618 - 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 - US Nationwide including Guam and Puerto Rico; 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 Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

Model: V60 Part Number: R1053618 V60 Ventilator, Japan Opt: CFLEX,AVAPS Serial Numbers: 100039155 100054624 100054738

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 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

12 other products · FDA event 86697

This product is part of a recall event; the main page for the event is Philips Respironics V60 Ventilator recalled by Respironics California.

Reported	Class	Recall	Company	Reason	Where
3 Feb 2021	CLASS II	Philips Respironics V60 Ventilator recalled by Respironics California	Respironics California	Other	Nationwide
3 Feb 2021	CLASS II	Philips Respironics V60 Ventilator recalled by Respironics California	Respironics California	Other	Nationwide
3 Feb 2021	CLASS II	Philips Respironics V60 Ventilator recalled by Respironics California	Respironics California	Other	Nationwide
3 Feb 2021	CLASS II	Philips Respironics V60 Ventilator recalled by Respironics California	Respironics California	Other	Nationwide
3 Feb 2021	CLASS II	Philips Respironics V60 Ventilator recalled by Respironics California	Respironics California	Other	Nationwide
3 Feb 2021	CLASS II	Philips Respironics V680 Ventilator recalled by Respironics California	Respironics California	Other	Nationwide
3 Feb 2021	CLASS II	Philips Respironics V60 Ventilator recalled by Respironics California	Respironics California	Other	Nationwide
3 Feb 2021	CLASS II	Philips Respironics V60 Plus Ventilator recalled	Respironics California	Other	Nationwide
3 Feb 2021	CLASS II	Philips Respironics V60 Ventilator recalled by Respironics California	Respironics California	Other	Nationwide
3 Feb 2021	CLASS II	Philips Respironics V60 Ventilator recalled by Respironics California	Respironics California	Other	Nationwide
3 Feb 2021	CLASS II	Philips Respironics V60 Plus Ventilator recalled	Respironics California	Other	Nationwide
3 Feb 2021	CLASS II	Philips Respironics V60 Ventilator recalled by Respironics California	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
27 Apr 2022Device	CLASS I	Philips Respironics V680 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

Other CPAP & Ventilators recalls

All 556

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2 Sep 2026Device	CLASS II	Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled	Medline Industries	Device Malfunction	Nationwide