Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B

Class I - Dangerous

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    Model number: DS2000X11B, UDI-DI: 606959052000. Serial Numbers: H27736231F4BE, H277362379188, H27736246CD09, H277372867812, H27737288916C, H2773729661CA, H27737302AA2A, H27737306EC0E, H2773730914F9, H27737331B2D9, H27737344A87C, H277373468B6E, H277373596A41, H277373815671, H2773738401DC, H2773740998FC, H277374132E7E, H277374212704, H277374525897, H277374740E11, H277374848DD9, H27737492F137, H27737496B713, H277375206C51, H277375242A75, H2773757677DF, H277375789EA1, H27737583A3BA, H27737593BA62, H27737607C43A, H27737614EF79, H27737624C511, H27737635CD40, H27737646B2D3, H27737656AB0B, H27737664A271, H2773767871C5, H277376870AFA, H27737700EA59, H27737702C94B, H277378459053, H27737846A2C8, H27737847B341, H27737853ECBD, H277378549802, H27737869698F, H277378779929, H277378925494, H277378970339, H2773792845BA, H27737966CBA4, H27737971A6C3, H277379821790, H2773801950BC, H27738021F69C, H277380378A72, H27738043815E, H27738052890F, H27738057DEA2, H277380680C3D, H277380801A65, H277380867F53, H27738088962D, H277380933126, H277381019FF0, 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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, H2
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.
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 Universal Portable Electric Ventilator, Model Number DS2000X11B

Product Codes/Lot Numbers:

Model number: DS2000X11B, UDI-DI: 606959052000. Serial Numbers: H27736231F4BE, H277362379188, H27736246CD09, H277372867812, H27737288916C, H2773729661CA, H27737302AA2A, H27737306EC0E, H2773730914F9, H27737331B2D9, H27737344A87C, H277373468B6E, H277373596A41, H277373815671, H2773738401DC, H2773740998FC, H277374132E7E, H277374212704, H277374525897, H277374740E11, H277374848DD9, H27737492F137, H27737496B713, H277375206C51, H277375242A75, H2773757677DF, H277375789EA1, H27737583A3BA, H27737593BA62, H27737607C43A, H27737614EF79, H27737624C511, H27737635CD40, H27737646B2D3, H27737656AB0B, H27737664A271, H2773767871C5, H277376870AFA, H27737700EA59, H27737702C94B, H277378459053, H27737846A2C8, H27737847B341, H27737853ECBD, H277378549802, H27737869698F, H277378779929, H277378925494, H277378970339, H2773792845BA, H27737966CBA4, H27737971A6C3, H277379821790, H2773801950BC, H27738021F69C, H277380378A72, H27738043815E, H27738052890F, H27738057DEA2, H277380680C3D, H277380801A65, H277380867F53, H27738088962D, H277380933126, H277381019FF0, 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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, 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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, H2

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1289-2023

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.

Oct 7, 2025 Other Medical Devices Nationwide View Details →