Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides…
Medical device recall Z-0493-2022. Published in FDA’s Enforcement Report on Feb 2, 2022.
- 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 Feb 2, 2022. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- 17 states named in where it went
- 473 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?
Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg.
473 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 00606959051942 (USA); 00606959055483 (Korea) Product Identifier (Serial Numbers): H312385987BBD H31238613E4CA H31241259862E H31241349C52A H312413624849 H31246293D7F5 H29069399D107 H29669926A6D8 H296700951ED2 H296701855DD6…
Every code shown here, 1,994 characters
UDI-DI: 00606959051942 (USA); 00606959055483 (Korea) Product Identifier (Serial Numbers): H312385987BBD H31238613E4CA H31241259862E H31241349C52A H312413624849 H31246293D7F5 H29069399D107 H29669926A6D8 H296700951ED2 H296701855DD6 H29674238FF13 H296742474AEC H31220934079E H312209523678 H31220968B34A H280964980B5B H2967018997BA H296723150600 H2967242692F6 H296742253D2E H29674250278B H312207401CA9 H312208968320 H312209071F6D H31220910720A H3122091706B5 H31220928D42A H29670062E9A5 H29670177FD0C H2967017805FB H29672401D5F9 H29672403F6EB H29674270143B H297843621AFA H312413504133 H312209241E46 H312209466984 H2967239902AC H31220819B517 H312208463358 H31220879E1C7 H3122089792A9 H3122092149EB H3122086600E8 H3122093262A8 H31220939DC7B H31220950156A H312209603F02 H31220996D9FC H3122081028D6 H3122083329FD H31220840566E H312208540992 H3122086065DE H31220844104A H312209006BD2 H31220908E79A H3122093041BA H311986468D0A H31198653C37F H31198703E71B H311987378B57 H31199129B193 H311991651C9F H312002723AE6 H3120033750F7 H3120041817B5 H31200649CD3C H3120080642B0 H312008165B68 H312010168111 H3120105192CE H312010580F0F H31201122B781 H31201136E87D H31201153EB00 H31201160F3F3 H31206064B82A H31238478BB71 H31238600CF89 H312386149075 H31238626990F H312413562405 H312413642D7F H312413653CF6 H312413671FE4 H312413707283 H31245188BA57 H31246258C086 H3124630068AA H29670055B772 H29670089CD66 H29670120F70B H29670195440E H296723243DE1 H29672330621D H2967240593DD H29672456DFFE H296742224991 H29784208BBAC H312209272CDD H312209400CB2 H31192401F7C3 H311924097B8B H311924178B2D H3119242493DE H31192433FEB9 H31192470AB42 H3119247399D9 H31192474ED66 H31216909A045 H31216910245C H3121691573F1 H31217046BF77 H312170485609 H31217092492B H31217104A1D9 H312171178A9A H31217131DC1C H31217132EE87 H312171348BB1 H312171359A38 H31217137B92A H312171395054 H31217140809D H31217142A38F H31217146E5AB H312171491D5C H312171509945 H31217152BA57 H31217154DF61 H31217156FC73 H31217158150D H312171590484 H31217161A2A4 H3121716381B6…
FDA’s list runs to 7,187 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: Distributed to the following US states: AR, CO, FL, IA, IL, KY, LA, MI, MT, OH, PA, TN, TX, UT, VA, WV, and WY; and Distributed to the following foreign countries: Argentina, Brazil, Romania, and Netherlands.
The states and territories these words name
17 states and territories.
Every one of them
- Arkansas
- Colorado
- Florida
- Iowa
- Illinois
- Kentucky
- Louisiana
- Michigan
- Montana
- Ohio
- Pennsylvania
- Tennessee
- Texas
- Utah
- Virginia
- West Virginia
- Wyoming
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Dec 22, 2021.
- FDA classified it on Jan 21, 2022.
- FDA’s Enforcement Report published it on Feb 2, 2022.
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 7,187 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.