Philips Respironics V60 Ventilator
Medical device recall Z-0897-2021. 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
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 54 states named
- 835 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?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
835 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model: V60 Ventilator, Part Number 1137276 V60 Ventilator, Intl Opt CFLEX, AVAPS 3.00 SW Serial Numbers: 100286055 100286057 100286203 100286204 100286207 100289426 100289690 100289701 100289702 100289703 100289704 100289711 100291365…
Every code shown here, 1,995 characters
Model: V60 Ventilator, Part Number 1137276 V60 Ventilator, Intl Opt CFLEX, AVAPS 3.00 SW Serial Numbers: 100286055 100286057 100286203 100286204 100286207 100289426 100289690 100289701 100289702 100289703 100289704 100289711 100291365 100291472 100291487 100291842 100309654 100309725 100309726 100309728 100311169 100311171 100314702 100315038 100318590 100318593 100318613 100319271 100319286 100319296 100319298 100319300 100329969 100329972 100329979 100337251 100339218 100340917 100341273 100345558 100345603 100369688 100377935 100284364 100284366 100286200 100286201 100286202 100286206 100288337 100289430 100289495 100289498 100289684 100289700 100291197 100291363 100291364 100291370 100291468 100291473 100291474 100291724 100291732 100291825 100291833 100291837 100309647 100309649 100309653 100317131 100317280 100320643 100321695 100321704 100329980 100329985 100329990 100341375 100376390 100378223 100378238 100291839 100341895 100343575 100343606 100343657 100343665 100343671 100343688 100345123 100345523 100345524 100345525 100345549 100345562 100345600 100345601 100345615 100354424 100354462 100355897 100356203 100356210 100356213 100356261 100356269 100356285 100356293 100356296 100356305 100356768 100358348 100366950 100367148 100367154 100367160 100367182 100289100 100289422 100289423 100289424 100289425 100289427 100289428 100289431 100289433 100289434 100289436 100289437 100289438 100289480 100289481 100289482 100289485 100289492 100289496 100289680 100289686 100289697 100289698 100289699 100289705 100289706 100289707 100289712 100289713 100291367 100291450 100291464 100291465 100291467 100291469 100291470 100291475 100291477 100291479 100291481 100291482 100291483 100291484 100291485 100291486 100291725 100291726 100291727 100291728 100291729 100291731 100291734 100291735 100291736 100291738 100291829 100291831 100291832 100291834 100291838 100291844 100309579 100309648 100314677 100314683 100314696 100314698 100314699 100314700 100314701 100314703…
FDA’s list runs to 8,454 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 - 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.
The states and territories these words name
54 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- American Samoa
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Guam
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
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?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Oct 30, 2020.
- FDA classified it on Jan 22, 2021.
- FDA’s Enforcement Report published it on Feb 3, 2021.
- FDA terminated it on Sep 19, 2024.
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 8,454 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.