FDAFDA · Food and drugs·Recall number Z-1817-2024
OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
Published May 29, 2024 · Recall initiated: April 1, 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
Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Respironics, Inc.
- Distributor
- US Nationwide distribution and OUS International distribution to Canada.
- Lot
- Product Number / UDI-DI/ Serial Numbers: 1111122 / UDI-DI 606959067813 Serial Numbers L097964930206 L09796498BCD5 L09796510A481 L097965381B79 L0979657784EE L097965971EFE L09796767288E L09796779D828 L097968136965 L097968141DDA L097968163EC8 L09796818D7B6 L09796819C63F L097968225284 L09796823430D L0979682437B2 L09796825263B L097968270529 L09796829EC57 L0979684751F9 L09796849B887 L097968512D17 L097968521F8C L0981390546A9 L098140911CAA L098141339814 L100102519380 L10010275E614 L1001028123F8 L1001028565DC L1001028746CE L10010288BE39 L100102913A20 L100102975F16 L1001030394F6 L10010310BFB5 L100103138D2E L10010338004D L1001034596A0 L100103558F78 L1001039705CA L100104165686 L10010417470F L100104223ACA L100104300000 L103082023D42 L103905201559 L10638229B96A L1063826260D9 L106382750DBE L10638290C003 L106383073978 L106383114596 L1087900826E2 L10879015E4DF L11022823358F L1102293730AF L110456413EEF L110706047DB9 L110708377551 L11070894BABA L11070899615F L11070900715A L11070906146C L110709489A72 L110709500FE2 L11081466C984 L110815129874 L110815290CCF L110815669358 L110817023414 L11136407983B L112492807AC5 L11249288F68D L11249292400F L112492935186 L112492942539 L11249296062B L1124929717A2 L11249299FEDC L11249304A8FD L112493086291 L11249312D413 L122858118744 L12735071463D L12945235DBBF L1323076570C1 L13230766425A L1323076753D3 L13230768AB24 L13230769BAAD L1330033132DB L13300393ECB9 L186537949AFB L18653797A860 L21271600A5A0 L22035135ABA4 L22035136993F L220351387041 L2203513961C8 L22226897CF07 L2222689837F0 L22977035C06D L229770390A01 L22977042F9DA L22977043E853 L229770449CEC L229770458D65 L22977046BFFE L22977047AE77 L229770485680 L229770494709 L22977050C310 L22977051D299 ; 1111123 / UDI-DI 606959067820 Serial Numbers L111838125A56 L11249556238E L113839345E5A L114895520A60 L11489624CD3A L122772495544 L12277265AC98 L122820001EF6 L122820010F7F L122820023DE4 L12600251B785 L12600256C33A L14644753AA1B L14644754DEA4 L150166760CD7 L150166771D5E L15229405619F L16241620C614 L16241621D79D L16241622E506 L1738993901DC L17389941C09C L17389942F207 L173899494CD4 L17389950C8CD L17389952EBDF L184660920805 L18466093198C L184660946D33 L18498438FDF0 L18498439EC79 L184984403CB0 L18498646EC3E L18498647FDB7 L184986480540 L1849864914C9 L1849865090D0 L184986518159 L19346221FE02 L19346222CC99 L19346223DD10 L19715750880B L197157519982 L19715752AB19 L19715753BA90 L198887461387 L19888747020E L19888748FAF9 L198887535DF2 L19888754294D L1988875538C4 L198887615488 L198887626613 L19888763779A L19888769D8C0 L198887705CD9 L198887714D50 L2022020606CD L20220208EFB3 L20220209FE3A L22730349EBFE L227303517E6E L227303535D7C L2273035429C3 L22730355384A L227303560AD1 L227303571B58 L22964763796F L230947888DF6 L230947899C7F L230947901866 L2309479109EF L230947923B74 L230947932AFD L230947945E42 L230947954FCB L230947967D50 L230947976CD9 L23094798942E L2309479985A7 L243182821D60 ; 1111124/ UDI-DI 606959067837 Serial Numbers L097659502973 L097788972E7B L097893396594 L09789340B55D L0978980877D3 L097962635717 L097962725F46 L097964480CAD L09796455CE90 L097964692E94 L097964846F61 L097964857EE8 L09796488A50D L09796489B484 L09796490309D L097964912114 L09796501ACD0 L097965038FC2 L09796504FB7D L09796505EAF4 L09796506D86F L09796507C9E6 L097965083111 L097965092098 L097965128793 L09796515F32C L09796557B75E L0979660360A6 L097967663907 L09796769C1F0 L0979677045E9 L0979677403CD L0979677620DF L09796787B29E L097967884A69 L09796791CE70 L097968335AD5 L0981359240AD L098139144EF8 L09813981CE4D L0981398499E0 L09813986BAF2 L098141181577 L09814142C495 L09814144A1A3 L098141497A46 L098141804E27 L098141840803 L098523162F3B L09852388115D L098524268956 L10010204BA95 L100102096170 L100102481799 L10010255D5A4 L10010256E73F L10010260A861 L10010261B9E8 L100102628B73 L10010271A030 L1001027292AB L10010274F79D L100862831A14 L10086316C07D L100863208F23 L10086337E244 L10086351D3A2 L100863825141 L1008638525FE L100863906B8B L10119258F309 L10119259E280 L10119262763B L10119269C8E8 L101192704CF1 L1011927629C7 L10119286AA0F L101192
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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