Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, DE2110X13B, BL2110X15B, GB2110X15B, EU2110X15B, EE2110X15B, LD2110X23B, and VT2110X24B
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 606959051942 606959051959 606959051973 606959051980 606959055452 606959052307 606959055476 606959055483 606959055490 606959062092 606959055506 606959055513 606959055421 606959054080 606959054110 606959055520 606959054127 606959054981 606959055544 606959057432 606959062962; Serial Numbers: H316330493348 H31633062BE2B H31633067E986 H3163306900F8 H316330719568 H31633072A7F3 H31633073B67A H31633074C2C5 H31633077F05E H31633084410D H316330899AE8 H316330910F78 H316330923DE3 H3163309892B9 H31633102B027 H3168304974A4 H31683060DAD5 H31683061CB5C H31683081514C H3168308263D7 H3168308406E1 H31683087347A H31683088CC8D H31683090591D H316830927A0F H316830936B86 H316830941F39 H31683100D4D9 H31683101C550 H31683102F7CB H31696034875A H31696053A735 H31696059086F H316960638D5D H31696067CB79 H316960739485 H31696077D2A1 H3169608206C4 H3169608640E0 H316960921F1C H3169609748B1 H31696101A043 H31696105E667 H31696118245A H31696123B0E1 H317352405480 H317354480E11 H31735507CB5A H31735568677D H317359517577 H31735981C50F H317406346246 H3174065070B2 H317406543696 H317406740526 H31740679DEC3 H31740686A5FC H31740691C89B H31740696BC24 H31740701455F H317964963E72 H318068788452 H31806883B949 H31806884CDF6 H31806885DC7F H31806888079A H318368546042 H3183685571CB H318368564350 H31836858AA2E H31861740040C H3186181302E8 H318619467121 H3186198831FF H31862000CAA4 H31961173CE0D H320015337C89 H320015731BE9 H3204332184FC H32043326F043 H32107976A656 H321079795EA1 H321542678438 H321542687CCF H322097635A07 H32209769F55D H3220978697BA H32209790EB54 H322097968E62 H3220980430AF H322098117EDA H32209818E31B H322581438581 H32258144F13E H32258145E0B7 H32258146D22C H32258147C3A5 H323157817B5E H32315798FF47 H32315830C4B8 H32315965B771 H323159861FFA H323160033F44 H323160203E6F H3231604249AD H32316060590F H32316078CC9F H3231612247A1 H32316139E0AA H32316159B47A H32316167776C H32316185CE6E H323161890402 H323172129E16 H3231723802FC H32317242E0AE H3231726784B3 H32317301EF89 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- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Philips Respironics, Inc.
- Reason for Recall:
- Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, DE2110X13B, BL2110X15B, GB2110X15B, EU2110X15B, EE2110X15B, LD2110X23B, and VT2110X24B
Product Codes/Lot Numbers:
UDI-DI: 606959051942 606959051959 606959051973 606959051980 606959055452 606959052307 606959055476 606959055483 606959055490 606959062092 606959055506 606959055513 606959055421 606959054080 606959054110 606959055520 606959054127 606959054981 606959055544 606959057432 606959062962; Serial Numbers: H316330493348 H31633062BE2B H31633067E986 H3163306900F8 H316330719568 H31633072A7F3 H31633073B67A H31633074C2C5 H31633077F05E H31633084410D H316330899AE8 H316330910F78 H316330923DE3 H3163309892B9 H31633102B027 H3168304974A4 H31683060DAD5 H31683061CB5C H31683081514C H3168308263D7 H3168308406E1 H31683087347A H31683088CC8D H31683090591D H316830927A0F H316830936B86 H316830941F39 H31683100D4D9 H31683101C550 H31683102F7CB H31696034875A H31696053A735 H31696059086F H316960638D5D H31696067CB79 H316960739485 H31696077D2A1 H3169608206C4 H3169608640E0 H316960921F1C H3169609748B1 H31696101A043 H31696105E667 H31696118245A H31696123B0E1 H317352405480 H317354480E11 H31735507CB5A H31735568677D H317359517577 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H2641263614AC H264126732461 H264127320854 H264127859843 H264129045711 H2641294344CE H26412986BAC3 H26413155E259 H26413198901C H264142721D13 H26414394B8E9 H26414432ACAA H264144817A99 H2641449617FE H264207868E62 H264208035DC8 H264208576554 H264208630918 H264209146A73 H26420918A01F H26421000B52A H26421011BD7B H26421052E880 H264210861EDC H264211079B49 H26421131D417 H26421171B377 H264211921BFC H264252142D82 H264252215047 H264252500CC6 H264252730DED H26425286D988 H26425290A566 H26425297D1D9 H264253031A39 H264253462AF4 H264253643A56 H26425376009C H26425399627B H26425424D133 H26425427E3A8 H26425441D24E H26425461E1FE H26425462D365 H26425474AF8B H264254970700 H26425502DD69 H264255259A66 H26425542BA09 H26425564EC8F H264255931BF8 H264256177C78 H264256347D53 H264256461349 H26425669D80E H264256984A4F H26425714143F H264257225B61 H26425739FC6A H26425750357B H264257601F13 H2642576982D2 H2642577663FD H26425792BFC9 H2644512184BB H26445156BD0C H26445172C898 H264542072AA6 H264542235F32 H26454228E1E1 H264542644CED H264542723003 H2645428090D9 H264542919888 H264543110C94 H264543313F24 H264543507A7D H264543737B56 H26454578135C H26454591148D H264546003D78 H264546405A18 H264546515249 H26454653715B H26454695BDCD H264547060292 H264547241230 H264547373973 H264547523A0E H264547621066 H26454768BF3C H26454784EF40 H264548013CEA H2645481034BB H264548437898 H2645485415FF H264548724379 H2645487352F0 H26454874264F H264549117FEE H26454918E22F H264549341BF3 H26454985EED2 H2645500783A5 H26455054CF86 H264550738889 H264551391A6F H26455160F916 H264602157F4C H264602301B51 H264602354CFC H2646791147EF H264679676FD1 H264680510E68 H26469220FBEA H26469256D3D4 H26469379424F H264694199A9A H26470043DA3E H26470062F807 H26470072E1DF H26470177ECAE H26470294AB41 H264703576AA6 H264703839CFA H26470442A8D6 H264704518395 H26470542F20A H264706421D6E H2647079492FC H264708216B3E H26470897EAA0 H26470920206B H2647096733B4 H264711185C32 H26471166F844 H2647116900B3 H2647120205D4 H26471411F84E H26471562DD01 H264715797A0A H264717246AEF H2647175427E7 H2647205955CA H26472088F43B H2647214916CE H264721638A24 H264724159BA7 H2647273010DE H2647279861E6 H2647285448ED H26472994BB91 H26474256531F H264742990248 H26474431A5A9 H26474454A6D4 H2647448416AC H264745976733 H264746311011 H26482268B16F H26482309AEEA H264824029C3C H26492690D6CA H264927072FB1 H264927253F13 H26492758A9FE H26492783A755 H264928054664 H264929610E4C H26492996F93B H26493003F92B H26493012F17A H26493021E989 H26493041BD59 H264930609F60 H264930888938 H2649308998B1 H2649309890E0 H26493198CA3C H264952332D61 H264952734A01 H26495283C9C9 H26495288771A H26495318FADE H264953205CFE H264953250B53 H264953746462 H26495396DD60 H264954097E8A H264954178E2C H26495446E11D H264954518C7A H26495506DCA1 H265027453E8C H26502969D74B H2650424986C7 H26504261393F H26504295FCD3 H265043147946 H265043473565 H265043753C1F H26504385BFD7 H2650441381FC H265044484197 H26504464B84B H2650448356E4 H26504521D25A H26504542B411 H265047371B0C H265047547D47 H265048011E95 H2650483134FD H265048552609 H26504869C60D H26504873708F H265049206670 H2650492531DD H265049412329 H265049789480 H26504992A1CA H26505031EE84 H26505072BB7F H26505074DE49 H26505102ACAB H2650518373E2 H2650519058A1 H265072063C9D H26507229F7DA H265072564225 H26507285C0C6 H265073145C8B H265073313896 H265128918953 H26512900151E H265129133E5D H265129199107 H265129303F76 H265129330DED H265129374BC9 H265129506BA6 H2651295248B4 H265129542D82 H26512987AF61 H26512993F09D H26515792A62E H26515793B7A7 H265158032A78 H2651581110B2 H265158202B53 H26515829B692 H265158470B3C H265158750246 H26515890CFFB H265159114A6E H265159141DC3 H26516066CA0A H26516137FFE7 H265161594249 H265161779887 H265172520F45 H26517260063F H265172688A77 H2651727893AF H26517296E0C1 H265173132370 H26517328B7CB H265173471BEC H2651735430AF H26517379D8FA H265173958886 H26517426D2B0 H26517441F2DF H265174569FB8 H26517473FBA5 H2651749142A7 H26517503EC71 H265175148116 H26517526886C H26517531E50B H26517554E676 H26517571826B H26517584560E H265176288E76 H26517649CB2F H26517664237A H26517681EEC7 H26517734071E H26517739DCFB H2651775015EA H265177554247 H26517774607E H265178289E6D H265178514EA4 H2651787609AB H26527065F9E6 H265271308A2F H26527141D6AE H26527153EC64 H2652716691A1 H265271786107 H265272004F23 H265272015EAA H265272037DB8 H265285883357 H26528590A6C7 H26528591B74E H2652859285D5 H26528594E0E3 H26528596C3F1 H26528597D278 H265285993B06 H265286018F32 H26528602BDA9 H26528603AC20 H26528605C916 H26528609037A H265286108763 H2652861196EA H26528612A471 H265286180B2B H265286191AA2 H26528620AD0B H26528621BC82 H265286228E19 H26528625FAA6 H265286282143 H2652862930CA H26528631A55A H265286338648 H26528636D1E5 H26528637C06C H26528641E852 H265286487593 H26528649641A H26528650E003 H265286568535 H265286648C4F H265286827369 H26528702E775 H26
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1649-2023
Related Recalls
Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.
DreamStation Auto BiPAP. Non-Continuous Ventilator.
Philips Respironics
Devices may possess a programming error resulting in an incorrect device configuration.
DreamStation Auto. Non-Continuous Ventilator.
Philips Respironics
Devices may possess a programming error resulting in an incorrect device configuration.