Philips Trilogy 200 Ventilator
Medical device recall Z-0883-2023. 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
- 537 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 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 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B
537 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 00606959429154 00606959429208 00606959429147 00606959429185 00606959429710 00606959429611 00606959429475 00606959429260 00606959033986 00606959033993 00606959429444; Serial Numbers: TV212103056 TV213062024 TV214101606 TV210092113…
Every code shown here, 1,999 characters
UDI: 00606959429154 00606959429208 00606959429147 00606959429185 00606959429710 00606959429611 00606959429475 00606959429260 00606959033986 00606959033993 00606959429444; Serial Numbers: TV212103056 TV213062024 TV214101606 TV210092113 TV211113009 TV212022810 TV212062641 TV214031911 TV214040418 TV214040414 TV21404041D TV214041501 TV21404041C TV214061728 TV21406171F TV21412160E TV215030665 TV215100123 TV21706280E TV217092201 TV217122107 TV217122113 TV219090909 TV21909091B TV210081103 TV210082301 TV210092106 TV210102509 TV211051303 TV211080213 TV211092124 TV212051425 TV212062657 TV213042329 TV213050906 TV21402100B TV21403186A TV214040816 TV214060402 TV214100114 TV214100115 TV214102009 TV214102008 TV21507270A TV215100201 TV21608016D TV21608037C TV21608037B TV217120409 TV219090913 TV212062268 TV213121266 TV220111614 TV220112315 TV212062243 TV214081917 TV210072214 TV210072245 TV211060304 TV211060124 TV211060320 TV211060309 TV211092126 TV212020645 TV213012231 TV213042341 TV213092015 TV213102323 TV21401211B TV21401240B TV214021019 TV21402111E TV21403110F TV214030515 TV21403186E TV214052307 TV214060408 TV214070902 TV214072266 TV214081914 TV21408191E TV214100118 TV214101604 TV215010902 TV215040915 TV215051102 TV215061205 TV215061203 TV21506050A TV215072908 TV215082701 TV215082711 TV215091401 TV215092414 TV215093006 TV215100817 TV215100820 TV21510081E TV21511061D TV216021114 TV216021116 TV216021119 TV216021727 TV216021730 TV216031713 TV21603171B TV216031503 TV21603171C TV216040153 TV216041217 TV21604121E TV216062160 TV216110309 TV21612070B TV217062804 TV217062701 TV217062704 TV217062703 TV217062808 TV217062811 TV217090516 TV217112716 TV21711271A TV218020803 TV218021509 TV21802150C TV218021508 TV21802150E TV21806123A TV21806123F TV21806122E TV218061220 TV2180627B7 TV219041213 TV21904290E TV21906050D TV219101502 TV219101505 TV219101501 TV219111301 TV21912185D TV210110321 TV212041013 TV212051047 TV212062565 TV212062563 TV212103051 TV213012215 TV213022078 TV213081307 TV213082813…
FDA’s list runs to 6,642 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 6,642 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.