Recall archive / FDA device enforcement

Trilogy Evo Universal Ventilator, Model No. DS2000X11B — FDA record Z-2943-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 16, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Trilogy Evo Universal Ventilator, Model No. DS2000X11B
Reason: 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.
Classification: Class I
Recalling firm: Philips Respironics, Inc.
Quantity: 90,910 US; 56,273 ROW
Agency-reported status: Ongoing
Source record identifier: Z-2943-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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 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H311516346D43 H311517050C7E H31151729F5A2 H3115181008CC H31151827561B H311518407674 H31151886BAE2 H3...

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Details supplied by the agency

Lot, code or applicability

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 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H3095389262E5 H30953911C462 H3095391493CF H30953925A82E H30953935B1F6 H3095397190B2 H309540274003 H309540364852 H3095406415F8 H309540762F32 H30954138FBF0 H3095415311F3 H30954200B2B4 H30968284B0A8 H30982238237A H30994254FD18 H30995441790F H3099570685B4 H30997288A2C1 H30997305ED38 H30997311B2C4 H309973182F05 H30997323BBBE H30997328056D H30997332B3EF H30997335C750 H309973390D3C H30997342FEE7 H309973449BD1 H3099734851BD H309973548209 H309973584865 H30997364A861 H30997365B9E8 H309973778322 H309973807455 H309973861163 H3099738700EA H309973917C04 H309973953A20 H30997399F04C H30997407422F H30997408BAD8 H309974222632 H30997427719F H309974301CF8 H309974354B55 H3099744634C6 H31087465840F H31087553918D H31087562AA6C H31087626644C H310876345E86 H31087805757C H310878399578 H31087845121C H310878550BC4 H3108786702BE H310878753874 H310879721617 H310880798623 H31088086FD1C H310881000C36 H31088134607A H31088159EF4F H310881663DD0 H3108817373A5 H310911738182 H310932156676 H310932267E85 H31093380BC1F 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H31107389067D H31107402FA6B H3110743787AE H3110745284D3 H311074781839 H311075181635 H311075292DD4 H31107535FE60 H31107571DF24 H311075862853 H311076035E5A H311076134782 H31107629C2B0 H311076444D85 H311077113E4C H311077354BD8 H31107742726F H311078273BD5 H3110783056B2 H311078363384 H3110784238A8 H31115401FAC2 H311165962674 H311166052C93 H31116819EF3C H311407755689 H3114095647B9 H31140972322D H311409890F36 H31141002FF80 H311410184902 H31141050A22A H31141063BAD9 H311410691583 H311410845476 H311410977F35 H31141113AD0D H3114112839B6 H31141141F0A7 H31141167A621 H311422413A0E H311422733374 H31142285D58A H31142299063E H311423133D78 H31142348FD13 H311423615362 H311423714ABA H311423849EDF H311423948707 H31142404DC1A H31142416E6D0 H31142429344F H31142471C6BF H311424850353 H311424951A8B H31142547D33D H31142567E08D H311425833CB9 H311425932561 H311426276889 H3114264048E6 H3114265140B7 H311426661E60 H31142684A762 H311426969DA8 H311427135E19 H311427982E0A H311428120557 H311428244A09 H31142833276E 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H31151729F5A2 H3115181008CC H31151827561B H311518407674 H31151886BAE2 H3...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Sep 11, 2024
Recall initiation date: Jul 16, 2024
Center classification date: Sep 4, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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