Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 606959052017 606959056497 606959061033 606959052321 606959058613 606959058620 606959058644 606959058668 606959058675 606959058682 606959058705 606959058798; Serial Numbers: H800088856BDC H800088865947 H80008889A1B0 H800088913420 H8000889206BB H800089218A54 H295004989AF7 H295005081733 H29500526CDFD H29500537C5AC H29500543CE80 H29500550E5C3 H29500557917C H29500562ECB9 H2950058276A9 H29500589C87A H295005940A47 H2950064102F6 H29500644555B H2950064767C0 H295006500AA7 H295006566F91 H295006577E18 H295006599766 H29500695F4AA H295007020DD1 H29500710371B H29500716522D H295007210CFA H2950072769CC H295007333630 H29500748C5EB H29500782C311 H29500785B7AE H29500791E852 H29500808E84C H295008107DDC H2950081618EA H295008304E6C H295008362B5A H295008400364 H2950084554C9 H2950086030D4 H2950086213C6 H29500867446B H295008731B97 H29500878A544 H29500881BB4D H29500883985F H29500885FD69 H295109734A0F H295684188A77 H29568454277B H295684894CE6 H2956852613BD H295702706AAA 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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 O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B
Product Codes/Lot Numbers:
UDI-DI: 606959052017 606959056497 606959061033 606959052321 606959058613 606959058620 606959058644 606959058668 606959058675 606959058682 606959058705 606959058798; Serial Numbers: H800088856BDC H800088865947 H80008889A1B0 H800088913420 H8000889206BB H800089218A54 H295004989AF7 H295005081733 H29500526CDFD H29500537C5AC H29500543CE80 H29500550E5C3 H29500557917C H29500562ECB9 H2950058276A9 H29500589C87A H295005940A47 H2950064102F6 H29500644555B H2950064767C0 H295006500AA7 H295006566F91 H295006577E18 H295006599766 H29500695F4AA H295007020DD1 H29500710371B H29500716522D H295007210CFA H2950072769CC H295007333630 H29500748C5EB H29500782C311 H29500785B7AE H29500791E852 H29500808E84C H295008107DDC H2950081618EA H295008304E6C H295008362B5A H295008400364 H2950084554C9 H2950086030D4 H2950086213C6 H29500867446B H295008731B97 H29500878A544 H29500881BB4D H29500883985F H29500885FD69 H295109734A0F H295684188A77 H29568454277B H295684894CE6 H2956852613BD H295702706AAA H295702771E15 H29570309E0BF 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H293398904F49 H2933989518E4 H293398962A7F H2933990484A9 H29339906A7BB H293399095F4C H29339910DB55 H29339912F847 H293399149D71 H29339917AFEA H293399296CFC H29339930E8E5 H29339931F96C H29339933DA7E H29339935BF48 H293399368DD3 H29339940A5ED H29339941B464 H29339944E3C9 H29339946C0DB H29339949382C H293399529F27 H29339958307D H29339960965D H29339962B54F H29339964D079 H29339965C1F0 H29339974C9A1 H293399822F5F H293399844A69 H29339986697B H293399888005 H29339989918C H293399901595 H29339991041C H293399923687 H29339993270E H2933999453B1 H293399954238 H2933999670A3 H29340002B43E H29340004D108 H29340007E393 H293400081B64 H293400090AED H29340012ADE6 H29340013BC6F H29340014C8D0 H29340017FA4B H2934001802BC H29340029395D H29340031ACCD H293400329E56 H29340034FB60 H29340036D872 H29340037C9FB H293400392085 H29340051F81D H29340052CA86 H29340053DB0F H29340054AFB0 H2934005865DC H29340061D275 H29340063F167 H293400659451 H29340066A6CA H29340073E8BF H293400836B77 H293400841FC8 H293400850E41 H293400863CDA H293400872D53 H29340089C42D H293400940610 H293400951799 H293400962502 H293401095031 H29340112F73A H29340113E6B3 H29340114920C H293401158385 H29340116B11E H293401185860 H2934011949E9 H29340120FE40 H29340125A9ED H293401269B76 H293401278AFF H293401287208 H29340132C48A H29340134A1BC H29340135B035 H2934013682AE H293401379327 H293401386BD0 H293401397A59 H293401493751 H29340150B348 H2934016188A9 H29340162BA32 H29340163ABBB H29340164DF04 H29340165CE8D H29340166FC16 H293401681568 H2934016904E1 H2934017080F8 H29340185549D H293415092FEB H293416253953 H293416343102 H293416465F18 H29341660099E H293416701046 H29341687E731 H29341695DDFB H29341747144D H293417543F0E H2934176504EF H293417762FAC H293417848F76 H29341793E211 H29341828F2AD H29341848A67D H29341876656B H29341893A8D6 H293419032512 H293419133CCA H293419303DE1 H29341981C8C0 H29341995973C H29341997B42E H29342000AE5A H29342014F1A6 H29342022BEF8 H293420308432 H29342038087A H2934204954FB H293420797E93 H29342089FD5B H29342111FCD7 H29342125909B H293421856DEB H293422001BE2 H2934322217FB H293432230672 H2934322651DF H29343229A928 H293432302D31 H293432320E23 H293432331FAA H29343237598E H2934324352A2 H29343244261D H293432453794 H29343246050F H293432471486 H29343248EC71 H29343249FDF8 H2934325079E1 H293432516868 H293432525AF3 H29343262709B H293432636112 H2934326415AD H293432650424 H2934327378CA H293432773EEE H29343280C999 H29343281D810 H29343282EA8B H29343283FB02 H293432949665 H2934329587EC H29343296B577 H29343297A4FE H293432985C09 H293432994D80 H293433027E97 H293433050A28 H2934330638B3 H29343307293A H29343308D1CD H29343309C044 H2934331155D4 H29343312674F H293433235CAE H293433242811 H293433260B03 H293433271A8A H29343329F3F4 H2934333077ED H293433316664 H293459134E26 H29345927226A H2934598288B7 H29345985FC08 H29345996D74B H29346002FFA4 H29346011D4E7 H2934601592C3 H2934601958AF H29346023DD9D H29346040BBD6 H29346056C738 H29346072B2AC H293460944D8A H29346106E35C H29346116FA84 H293461339E99 H29346146843C H29346158749A H29346209F4CF H29346218FC9E H29346239DEA7 H2934625017B6 H293462630F45 H29346281B647 H29346287D371 H29346297CAA9 H293463157DA7 H293463244646 H2934633895F2 H29346345031F H29346358C122 H2934636530AF H293463734C41 H2934722732BA H293472363AEB H2934725996CC H293472712934 H29347294E489 H293473473CB6 H29347436EC32 H29347532F0CA H29347542BDC2 H29347553B593 H29347565FACD H29347576D18E H293475865246 H29347599B369 H2934760673E2 H2934773177E9 H2934774319F3 H29347930767B H293480262472 H293480498855 H293480721CEE H29348084FA10 H29348118BDB8 H293481300240 H293481505690 H293481625FEA H29348178E968 H29349809354C H293498183D1D H293498209B3D H29349822B82F H29349824DD19 H29349827EF82 H293498281775 H29349834C4C1 H293498380EAD H29349840CFED H2934984489C9 H293498459840 H29349846AADB H29349847BB52 H29349850D635 H29349853E4AE H29349856B303 H293498594BF4 H29349860FC5D H29349862DF4F H2934986788E2 H29349870E585 H29349873D71E H2934987680B3 H29349880664D H29349882455F H2934988531E0 H293498907F95 H293498934D0E H29349898F3DD H29349901E3D8 H29349903C0CA H29349905A5FC H2934990786EE H293499096F90 H29349911FA00 H29349913D912 H293499284DA9 H29349930D839 H29349933EAA2 H293499358F94 H29349936BD0F H29349937AC86 H293499385471 H293499409531 H29349943A7AA H29349945C29C H293499481979 H29349953BE72 H29349954CACD H29349957F856 H293499591128 H29349963941A H29349966C3B7 H293499682AC9 H293499729C4B H29349974F97D H29349977CBE6 H293499803C91 H293499821F83 H293499830E0A H29349987482E H29349989A150 H29349992065B H2934999317D2 H2934999572E4 H2934999751F6 H29350004DA4C H29350007E8D7 H29350015D21D H29350017F10F H293500239D43 H29350024E9FC H29350025F875 H29350026CAEE H29350212131A H2935022328FB H293502634F9B H29350284A134 H29350295A965 H2935030524A1 H293503153D79 H29350326258A H29350339C4A5 H293503511C3D H2935035881FC H293503730C9F H29350386D8FA H29350395F3B9 H29350405A8A4 H293521591CBB H29352160AB12 H29352161BA9B H293521628800 H293521639989 H29352164ED36 H29352165FCBF H29352166CE24 H29352167DFAD H29352168275A H2935216936D3 H29352170B2CA H29352171A343 H2935217291D8 H293521738051 H29352174F4EE H29352175E567 H29352176D7FC H29352177C675 H293521783E82 H293521792F0B H293521803102 H29352181208B H293521821210 H293521830399 H293521847726 H2935218566AF H293521865434 H2935218745BD H29352188BD4A H29352189ACC3 H2935219028DA H293521913953 H293521920BC8 H29361692BFCC H29361699011F H293617089D52 H293617177C7D H2936172201B8 H293844179CF6 H293844358C54 H29384444D0D5 H293844490B30 H29384457FB96 H293844693880 H29384475EB34 H293844812ED8 H293914805A42 H29391498CFD2 H29391499DE5B H29391502ED4C H29391503FCC5 H29391504887A H2939150599F3 H29391506AB68 H29391507BAE1 H293915084216 H29391509539F H2939160313A1 H2939164374C1 H2939164732E5 H29391655082F H293916652247 H293916724F20 H29391677188D H29391683DD61 H29391690F622 H2939170
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1651-2023
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.