Trilogy Evo O2 and LifeVent EVO2
Medical device recall Z-1650-2023. Published in FDA’s Enforcement Report on Jun 14, 2023.
- 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 Jun 14, 2023. 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 for where it went
- 21,520 devices 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?
Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, EU2100X15B, EU2100X19, EE2100X15B, and SP2100X26B
21,520 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 606959051997 606959054059 606959055575 606959061019 606959055599 606959055636 606959062085 606959055643 606959055650 606959055438 606959054097 606959054103 606959055674 606959055681 606959055698 606959057456; Serial Numbers:…
Every code shown here, 1,997 characters
UDI-DI: 606959051997 606959054059 606959055575 606959061019 606959055599 606959055636 606959062085 606959055643 606959055650 606959055438 606959054097 606959054103 606959055674 606959055681 606959055698 606959057456; Serial Numbers: H236054270DD5 H23630215A1ED H23630353F967 H23708996882F H24371560D579 H24762460B180 H24762461A009 H24762464F7A4 H255384963A07 H255386624A53 H25781923C0A4 H2578201604B2 H257820401F3C H257820445918 H25782086D3AA H25782201DC6D H25787261E6EA H2578730964AE H25787344D82B H2578742046DA H257930337750 H257930373174 H25793039D80A H25793041194A H257930433A58 H257930444EE7 H257930477C7C H25793048848B H25793050111B H257930510092 H257930532380 H2579305546B6 H25793056742D H257930589D53 H257930612AFA H257930621861 H2579306309E8 H257930656CDE H257930665E45 H25793068B73B H257930713322 H2579307201B9 H25793074648F H257930757506 H25793085F6CE H257930929BA9 H25958981A273 H25960485E33C H259605245519 H259838090646 H260429505975 H26079674BBFF H262014691128 H26201588C06D H262017323E27 H262018544506 H26235313105F H262468357A6E H26256287C5EA H26256295FF20 H262563002549 H2625630134C0 H262563289AB1 H262563404229 H26256353696A H26259915AABF H262602426DB1 H26260403CD81 H26260614155E H26260629E4D3 H2626063060CA H262607067548 H26260819DEA0 H262608513588 H2626088909B8 H262608908DA1 H262609000065 H2626092475F1 H26260948EB4D H262609650318 H2626099580D0 H262610840824 H262610936543 H26261102F90E H26261153963F H262611955AA9 H26264213706C H262642447A6B H26264295DB9A H262643435408 H26294959FB0C H26295126948A H262952013CE1 H262962198CBC H2630989379EA H263099095B74 H26309950B80D H263099529B1F H263455889BBA H263456065360 H26345663501D H263456878C29 H263759152F28 H26376023D9A5 H263761109B8A H26376141F4BB H26376148697A H26381224257F H26381297F34C H26381348E11F H26381427C13D H26381523DDC5 H263905954BA4 H2639063559B0 H2639064737AA H26390649DED4 H26390684AC91 H26390708F2E1 H263907423ADB H263907566527 H26390791B838 H26436123B2B8 H26436132BAE9 H26436165B0EE H264361807D53 H264442115D0C…
FDA’s list runs to 301,521 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.
US Nationwide. Global Distribution.
These words name no state.
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.
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 May 1, 2023.
- FDA classified it on Jun 2, 2023.
- FDA’s Enforcement Report published it on Jun 14, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Respironics, Inc., of Murrysville, PA.
- 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 301,521 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.