Trilogy Evo Universal Ventilator
Medical device recall Z-2943-2024. Published in FDA’s Enforcement Report on Sep 11, 2024.
- 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 Sep 11, 2024. 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
- 90,910 US; 56,273 ROW 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?
Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
90,910 US; 56,273 ROW, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 606959052000 US Serial Numbers H28984740CF4E H28984800E2E9 H3069350132A0 H30753614E0AA H30789237223A H307892401B8D H307892445DA9 H307892476F32 H307892646E19 H307892657F90 H30789268A475 H30789269B5FC H30803946EC1A H308039813105…
Every code shown here, 1,999 characters
UDI-DI: 606959052000 US Serial Numbers H28984740CF4E H28984800E2E9 H3069350132A0 H30753614E0AA H30789237223A H307892401B8D H307892445DA9 H307892476F32 H307892646E19 H307892657F90 H30789268A475 H30789269B5FC H30803946EC1A H308039813105 H308040536950 H308040753FD6 H30804091E3E2 H30804129D1DE H3081539229E2 H3081768676D5 H30817950E95C H3081837986AE H30828473B83D H30828515D307 H30835691344C H308357380E21 H308357448945 H30835753E422 H30835756B38F H30835772C61B H3083577791B6 H308357786941 H30835794393D H30835853AEE5 H3083585901BF H30835863848D H30835900B81A H30882857F80C H308829934D54 H308830388E52 H308830607CA2 H30883068F0EA H3088307532D7 H308830868384 H30883094B94E H30883120411E H30883128CD56 H30883139C507 H308831511D9F H3088315991D7 H308831703FA6 H30883178B3EE H308831883026 H308832009DCA H308862087FD5 H308862179EFA H30886226A51B H30886231C87C H308862418574 H30886253BFBE H308862682B05 H30886334C50D H30886337F796 H308863391EE8 H30886342ED33 H308863448805 H3088634953E0 H30886353E562 H30886363CF0A H30886371F5C0 H308863817608 H308864130E07 H308864377B93 H30886449DFE5 H3088646437B0 H308864735AD7 H30886484ADA0 H308864987E14 H308865070B27 H30886519FB81 H30886529D1E9 H3088656319D3 H30886573000B H3088658383C3 H308866090D3D H30886616EC12 H30886624E568 H30886635ED39 H30886643C507 H308866487BD4 H30886661D5A5 H308866684864 H308866814FB5 H30886689C3FD H3088669401C0 H308867690331 H30886775D085 H308867780B60 H308867791AE9 H308867901D38 H30886830AA8F H30886840E787 H308868486BCF H308868587217 H3088686949F6 H30886876A8D9 H30889425F3A0 H30889434FBF1 H308894850ED0 H30889562BAA3 H308895844585 H308895967F4F H30889609BFC4 H308896267483 H30896192E3B7 H30896196A593 H308961984CED H30896201E950 H30896203CA42 H3090220588D7 H30902206BA4C H3090220942BB H309022438A81 H30902245EFB7 H30902247CCA5 H30902250A1C2 H30902251B04B H3090225282D0 H309022539359 H30908936652C H3090895277D8 H30908970677A H309091168CE5 H30909136BF55 H30909157FA0C H309091920401 H309122691D2F H30912295548B H30912321ACDB H3091234865CA…
FDA’s list runs to 140,028 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) and OUS (foreign) countries of: AU, BD, BE, BG, BO, BR, BS, CH, CL, NL, CN, CO, CZ, DE, DK, FR, SE, GB, GF, GR, GT, HK, HR, HU, IE, IL, IN, IT, JP, KE, KW, LB, LT, MA, ME, MA, MT, MQ, MX, NO, NP, OM, PA, PE, PF, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SI, SK, SG, TH, TN, TR, TW, UA, YT, ZA and ZW.
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.
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 Jul 16, 2024.
- FDA classified it on Sep 4, 2024.
- FDA’s Enforcement Report published it on Sep 11, 2024.
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 140,028 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.