Philips Respironics V60 Ventilator
Medical device recall Z-0903-2021. Published in FDA’s Enforcement Report on Feb 3, 2021.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 3, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 9,856 systems (Amended on 07/29/2021 - 5 U.S. systems for faceplate replacement) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
9,856 systems (Amended on 07/29/2021 - 5 U.S. systems for faceplate replacement), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model: V60 Part Number: 1053614 V60 Ventilator,Intl Opt: CFLEX,AVAPS Serial numbers: 100007217 100021204 100021286 100021400 100029451 100042750 100042939 100043085 100055703 100056018 100062163 100062178 100063153 100063155 100063162…
Every code shown here, 1,995 characters
Model: V60 Part Number: 1053614 V60 Ventilator,Intl Opt: CFLEX,AVAPS Serial numbers: 100007217 100021204 100021286 100021400 100029451 100042750 100042939 100043085 100055703 100056018 100062163 100062178 100063153 100063155 100063162 100063293 100063300 100069697 100069744 100069860 100070577 100070772 100132058 100133634 100144871 100144874 100144879 100144961 100144982 100162731 100162792 100169641 100195675 100219970 100219972 100219975 100219999 100220001 100221150 100239619 100243227 100246517 100247269 100252596 100252597 100252600 100252764 100252768 100252771 100252772 100252773 100252797 100253477 100253484 100253492 100253493 100253494 100253500 100254739 100286208 100286300 100311170 100317381 100317392 100318233 100318405 100318406 100318408 100318413 100318415 100318416 100318426 100318615 100318623 100336755 100336849 100336855 100336889 100336895 100336900 100337085 100337258 100337260 100337261 100343560 100344202 100344235 100350181 100350684 100350711 100350714 100350914 100351156 100351157 100352118 100352139 100352147 100357135 100357137 100357139 100357454 100357456 100357458 100357459 100357733 100357797 100358125 100358129 100358131 100358134 100358149 100358151 100358154 100358155 100358162 100358164 100358198 100358302 100358304 100358319 100358337 100362568 100362701 100363015 100363053 100364545 100364554 100364602 100365186 100370897 100373551 100375010 100375148 100375226 100375243 100375267 100375280 100375282 100375283 201002610 201002611 201002976 201023090 201025859 201025954 201025966 201028012 201028033 201028528 201028889 201028898 201028988 201028990 201029030 201029045 201029138 201029937 201032702 201032705 201032707 201032713 201032718 201032733 201032831 201032863 201032871 100350289 100350298 100350670 100351154 100351541 100351555 100351712 100352113 100352824 100352946 100358347 100361419 100362450 100362575 100362703 100362721 100362745 100362746 100363013 100363030 100364252 100364503 100364521 100364532 100364539…
FDA’s list runs to 98,853 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
- Guam
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 2, 2020.
- FDA classified it on Jan 22, 2021.
- FDA’s Enforcement Report published it on Feb 3, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Respironics California, LLC, of Carlsbad, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 98,853 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.