FDAFDA · Food and drugs·Recall number Z-2943-2024
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
Published September 11, 2024 · Recall initiated: July 16, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Respironics, Inc.
- Distributor
- 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.
- Lot
- 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 H30912368567A H309123941FDE H30912458F017 H30912518CDAB H30912846A512 H30912873D8D7 H30912905AA35 H30912946FFCE H30912971A119 H309129975E3F H309130226D9F H309130445C79 H3091309398BE H309131201451 H30913143721A H309131771E56 H309131987CB1 H309133659124 H30913373EDCA H309133805C99 H3091339731FE H309134213C65 H30913428A1A4 H309134365102 H30913451716D H30913468C6C4 H30913490C944 H309135141B7C H30913607DF5B H30913647B83B H30913674A0C8 H30913715BF4D H309137902620 H30913817D698 H30913874B0D3 H30913904A707 H309139285EDB H30913965E25E H30913996530D H309140232B37 H309140541280 H30914078EB5C H30914608708D H309146409BA5 H3091467292DF H309146913A54 H30914845DC13 H30914864FE2A H309148831085 H309148912A4F H30914898B78E H30914904F026 H30914923B729 H30914934DA4E H30914962C1C0 H309149787742 H30915005610A H3091502552BA H30915043635C H3091506716C8 H309150878CD8 H3091511075A3 H30915155456E H30915178AD3B H30915198372B H30915217EE78 H309155033D81 H30915598544A H309156419697 H309156875A01 H30915704FC86 H3091573090CA H30915796088C H309158519F54 H3091586828FD H309158874A1A H309160365C34 H30916048F842 H309160524EC0 H3091605608E4 H309160673305 H309160714FEB H30916080DDAA H30916118DC26 H309161420DC4 H30917253F64A H309175157819 H30917540510C H30917594A750 H30917617B46F H30917799C90D H3091784933B2 H30917925F7D2 H309179478010 H30917995137A H30918007C997 H3092515992CE H30927265A4D8 H30927321DF40 H309273639B32 H30927376D547 H30927487CB03 H30927497D2DB H3092751300E3 H309275223B02 H30927643913F H309276844C20 H30927772F002 H309331617430 H309331725F73 H309347494A30 H30934752ED3B H30934820C9E6 H309348964878 H30934911A8DB H30934924D51E H309350130B6C H30935180B433 H30935199302A H30938397E763 H30938401D948 H309384059F6C H309384084489 H30938412F20B H30938413E382 H3093841586B4 H30938417A5A6 H30938423C9EA H309384269E47 H30938444E985 H30938456D34F H30938477F176 H309384910E50 H309385119A4C H30938514CDE1 H309385293C6C H30938540F57D H30938546904B H30938557981A H30938567B272 H3093857942D4 H309385836E46 H3093859731B
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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