Philips Trilogy 100 Ventilator
Medical device recall Z-0882-2023. Published in FDA’s Enforcement Report on Jan 18, 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 Jan 18, 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
- 20,807 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 replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655TPV, AU1054096, AU1054096B, 1054096B, 1054097, BR1054096, LA1054096, CN1054096, KO1054096, KR1054096, R1054655TP, R1054655B, 1054655, 1054655TPV, 1054655TP, 1054655B
20,807, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 00606959429055 00606959429253 00606959429093 00606959429130 00606959429048 00606959429680 00606959023178 00606959429246 00606959429079 00606959429086 00606959429697 00606959429116 00606959034037 00606959429321 00606959429314…
Every code shown here, 1,993 characters
UDI: 00606959429055 00606959429253 00606959429093 00606959429130 00606959429048 00606959429680 00606959023178 00606959429246 00606959429079 00606959429086 00606959429697 00606959429116 00606959034037 00606959429321 00606959429314 00606959429246 00606959429536 00606959429635 00606959429628 00606959429383 00606959429499 00606959429482 00606959034020 00606959429420 00606959429413; Serial Numbers: TV109102251 TV109102602 TV109111825 TV109111810 TV110030902 TV110042726 TV110051323 TV110062401 TV110062348 TV110102945 TV111042866 TV111061742 TV111062054 TV111061445 TV111062127 TV111062316 TV111121418 TV111121573 TV111121515 TV112022869 TV112051141 TV112051804 TV112070651 TV112091808 TV112092061 TV112092102 TV112092035 TV112111622 TV113061214 TV113042605 TV113043025 TV113050346 TV113052256 TV11311044D TV113082019 TV113091657 TV113110514 TV11310312F TV11311210C TV114011545 TV11401271C TV114110666 TV114022164 TV114022749 TV114022850 TV114030856 TV115021039 TV11403065E TV11405293E TV114061119 TV114062571 TV114063089 TV11408111A TV114082960 TV114090639 TV114100276 TV11410172B TV11503064B TV11504016A TV115042420 TV115032610 TV11505264D TV115032626 TV115032656 TV115061945 TV115072245 TV115081768 TV115091549 TV11510304C TV11604042A TV115072267 TV11709133A TV117030624 TV11708262B TV11712074F TV11801156B TV118030242 TV118030576 TV11803213F TV118050914 TV118051175 TV11805236D TV118053066 TV118082904 TV11809119B TV11809274A TV11810223F TV118103145 TV118112616 TV11902055A TV119032514 TV119052928 TV119080667 TV119081448 TV11908139E TV119112627 TV11709142F TV117091437 TV117091291 TV11709124B TV117101379 TV117110726 TV118042638 TV111050250 TV111092304 TV112012019 TV11606284A TV11706211D TV109090828 TV109091418 TV109090934 TV109092109 TV109121209 TV110030212 TV110033013 TV110032554 TV110033017 TV110033020 TV110042150 TV110043030 TV110043033 TV110042212 TV110042744 TV110050733 TV110051226 TV110061860 TV110061837 TV110081630 TV110092821 TV110092935 TV110102829 TV110102850 TV110102854…
FDA’s list runs to 250,087 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 and Global Distribution to countries of: Australia, Brazil, Canada, China, Germany, Japan, Korea, and Latin America.
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 Dec 7, 2022.
- FDA classified it on Jan 6, 2023.
- FDA’s Enforcement Report published it on Jan 18, 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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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 250,087 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.