Trilogy Evo Universal Ventilator
Medical device recall Z-1652-2023. 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
- 22,237 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?
The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and non-invasive ventilation.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Trilogy Evo Universal Ventilator, Model Number DS2000X11B
22,237 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 606959052000; Serial Numbers: H27736231F4BE H277362379188 H27736246CD09 H277372867812 H27737288916C H2773729661CA H27737302AA2A H27737306EC0E H2773730914F9 H27737331B2D9 H27737344A87C H277373468B6E H277373596A41 H277373815671…
Every code shown here, 1,998 characters
UDI-DI: 606959052000; Serial Numbers: H27736231F4BE H277362379188 H27736246CD09 H277372867812 H27737288916C H2773729661CA H27737302AA2A H27737306EC0E H2773730914F9 H27737331B2D9 H27737344A87C H277373468B6E H277373596A41 H277373815671 H2773738401DC H2773740998FC H277374132E7E H277374212704 H277374525897 H277374740E11 H277374848DD9 H27737492F137 H27737496B713 H277375206C51 H277375242A75 H2773757677DF H277375789EA1 H27737583A3BA H27737593BA62 H27737607C43A H27737614EF79 H27737624C511 H27737635CD40 H27737646B2D3 H27737656AB0B H27737664A271 H2773767871C5 H277376870AFA H27737700EA59 H27737702C94B H277378459053 H27737846A2C8 H27737847B341 H27737853ECBD H277378549802 H27737869698F H277378779929 H277378925494 H277378970339 H2773792845BA H27737966CBA4 H27737971A6C3 H277379821790 H2773801950BC H27738021F69C H277380378A72 H27738043815E H27738052890F H27738057DEA2 H277380680C3D H277380801A65 H277380867F53 H27738088962D H277380933126 H277381019FF0 H2773814974D8 H27738152D3D3 H27738154B6E5 H277381587C89 H27738160DAA9 H27738171D2F8 H27738176A647 H27738177B7CE H27738188CCF1 H277381963C57 H27742204CB4B H27742215C31A H27742217E008 H27742227CA60 H27742236C231 H27742240EA0F H27742245BDA2 H27742251E25E H27742262FAAD H27742273F2FC H2774229368EC H27742305801E H277423085BFB H27742321F58A H277423378964 H2774234293C1 H27742362A071 H277423691EA2 H27742377EE04 H277423823A61 H277423832BE8 H27742396659D H277424050C1B H277424072F09 H277424242E22 H277424253FAB H277424260D30 H27742428E44E H27742429F5C7 H27742439EC1F H2847032948F1 H28470375FC25 H284703930303 H28470409F744 H2847041707E2 H28470428D57D H284704444BC1 H284704647871 H284704828757 H284705573A5E H28470582DD8B H28470601CEB4 H28470617B25A H284706438AC6 H284706582DCD H284706832366 H284707019468 H28470716F90F H28470731BE00 H28470747963E H28470760D131 H28470776ADDF H28470810D6FE H28470823CE0D H284708493587 H284708609BF6 H28470998CEAA H284710122F95 H284710312EBE H2847105248F5 H284710727B45 H28471086BEA9 H284710984E0F H284711026C91 H28471105182E…
FDA’s list runs to 140,027 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 140,027 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.