Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10
Medical device recall Z-2073-2021. Published in FDA’s Enforcement Report on Jul 28, 2021.
- FDA Class I
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 Jul 28, 2021. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 48 states named
- Total of V60/V60 Plus = 23,115 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the “Cannot Reach Target Flow” alarm , the system will reduce pressure and simultaneously decreasing the flow rate to a level below what was set by the clinicians. If the reason for the increase in pressure is not resolved, the ventilator will continue to provide the lower flow rate, which result in patients experiencing oxygen desaturation which can be characterized as moderate or severe hypoxemia.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.
Total of V60/V60 Plus = 23,115 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model V60 Ventilator: P/N 1053613, 1053614, 1053615, 1053616, 1053617, DU1053617, U1053617, 1076716, 1137292 US System Serial Number/UDI Code: 100351272 (01)00884838020054(21)100351272 100006691 100193211 100220566…
Every code shown here, 1,999 characters
Model V60 Ventilator: P/N 1053613, 1053614, 1053615, 1053616, 1053617, DU1053617, U1053617, 1076716, 1137292 US System Serial Number/UDI Code: 100351272 (01)00884838020054(21)100351272 100006691 100193211 100220566 (01)00884838020054(21)100220566 100313757 (01)00884838020054(21)100313757 100313412 (01)00884838020054(21)100313412 100080135 100081569 100110187 100121703 100013472 100230650 (01)00884838020054(21)100230650 100374411 (01)00884838020054(21)100374411 100054305 100068863 100188390 100181283 100030036 100030039 100030046 100030040 100043349 100030041 100037246 201029401 (01)00884838020054(21)201029401 100278366 (01)00884838020054(21)100278366 100088340 100131320 201030489 (01)00884838020054(21)201030489 100057026 100074563 201005638 201001514 100027860 201005635 100154662 100056752 100130449 100154846 100078004 100055123 100191452 100077709 100015080 100191788 100129710 100028046 100077079 201017909 100224361 (01)00884838020054(21)100224361 100043830 100024302 100133355 100077493 100077503 100039424 100177846 201011206 100076877 100191271 100152171 100056385 100120289 100262177 (01)00884838020054(21)100262177 100120262 100047561 100156074 100104165 100115189 201026331 (01)00884838020054(21)201026331 100057549 100133002 100258925 (01)00884838020054(21)100258925 201030702 (01)00884838020054(21)201030702 100040748 100290605 (01)00884838020054(21)100290605 100044617 100147649 100038426 100049697 100318142 (01)00884838020054(21)100318142 100062636 100047178 100130954 100017106 100172675 100265434 (01)00884838020054(21)100265434 100097540 100174538 100028947 201033184 (01)00884838020054(21)201033184 100158623 100184938 100184879 100094731 100325804 (01)00884838020054(21)100325804 100117611 100048641 100267973 (01)00884838020054(21)100267973 100148068 100416709 (01)00884838020054(21)100416709 100118800 100177855 100023735 100025030 100040300 100279146 (01)00884838020054(21)100279146 100008228 100054315 100008224 100008438 100258476 (01)00884838020054(21)100258476…
FDA’s list runs to 34,651 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) to states of.: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and O.U.S. countries of: Andorra, United Arab Emirates, Albania, Argentina, Austria, Australia, Belgium, Canada, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, French Guiana, Guadeloupe, Greece, Hong Kong, Indonesia, Ireland, India, Iceland, Italy, Jordan, Kenya, Kuwait, Lebanon, Latvia, Libya, Morocco, Martinique, Malta, Mexico, Malaysia, New Caledonia, Nigeria, Netherlands, Norway, New Zealand, Philippines, Poland, Portugal, Qatar, R¿union, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, and South Africa.
The states and territories these words name
48 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- 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?
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 Jun 18, 2021.
- FDA classified it on Jul 21, 2021.
- FDA’s Enforcement Report published it on Jul 28, 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 34,651 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.