Philips Respironics V60 Ventilator
Medical device recall Z-0911-2021. 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
- 10,291 systems 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 1076716 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
10,291 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model: V60 Part Number: 1076716 V60 Ventilator, CHINA OPT: CFLEX, AVAPS Serial Numbers: 100193935 100194169 100030124 100030335 100030359 100030360 100030761 100030762 100030763 100030764 100030766 100030767 100030768 100030769 100030770…
Every code shown here, 1,998 characters
Model: V60 Part Number: 1076716 V60 Ventilator, CHINA OPT: CFLEX, AVAPS Serial Numbers: 100193935 100194169 100030124 100030335 100030359 100030360 100030761 100030762 100030763 100030764 100030766 100030767 100030768 100030769 100030770 100030771 100030773 100030775 100030776 100030777 100030779 100030782 100030783 100030784 100032461 100032686 100032687 100032688 100032689 100032690 100032691 100032692 100032695 100032697 100032698 100032701 100032702 100035773 100035778 100035779 100035896 100035897 100035898 100035899 100035900 100035901 100035902 100035903 100035904 100035907 100035909 100035910 100035911 100035913 100035914 100035918 100035919 100035926 100036047 100036302 100036306 100036307 100036310 100036311 100036313 100036314 100036316 100036317 100036320 100036432 100036433 100036434 100036439 100037365 100037366 100037367 100037368 100037369 100037370 100037371 100037372 100037373 100037374 100037375 100037376 100037377 100037378 100037379 100037380 100037382 100037383 100037384 100037385 100037386 100037387 100037388 100037389 100037390 100037391 100037392 100037393 100037394 100037395 100037541 100037542 100037548 100037551 100037559 100037561 100037562 100037563 100037564 100039784 100039789 100039973 100040077 100040088 100043091 100043304 100043306 100043307 100043308 100043309 100043310 100043311 100043312 100043318 100043320 100043321 100043941 100043942 100043943 100043946 100043947 100043950 100043953 100046144 100046153 100046155 100046158 100046160 100046161 100046162 100046163 100046546 100046745 100047058 100047068 100049056 100049057 100049058 100049059 100049060 100049061 100049062 100049063 100049064 100049065 100049068 100049069 100049070 100049072 100049076 100049077 100050076 100051086 100051087 100051090 100051091 100051092 100051093 100051094 100051095 100051096 100051097 100051098 100051320 100051321 100051322 100051323 100051324 100051325 100051326 100051327 100051328 100051329 100051330 100051332 100051333 100051334 100051335…
FDA’s list runs to 110,335 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 110,335 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
-
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.