Trilogy Evo Universal Ventilator, Model Number DS2000X11B — FDA record Z-1652-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 1, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
Trilogy Evo Universal Ventilator, Model Number DS2000X11B
Reason
The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and non-invasive ventilation.
Classification
Class I
Recalling firm
Philips Respironics, Inc.
Quantity
22,237 devices
Agency-reported status
Ongoing
Source record identifier
Z-1652-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityUDI-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 H2773814974D8 H27738152D3D3 H27738154B6E5 H277381587C89 H27738160DAA9 H27738171D2F8 H27738176A647 H27738177B7CE H27738188CCF1 H277381963C57 H27742204CB4B H27742215C31A H27742217E008 H27742227CA60 H27742236C231 H27742240EA0F H27742245BDA2 H27742251E25E H27742262FAAD H27742273F2FC H2774229368EC H27742305801E H277423085BFB H27742321F58A H277423378964 H2774234293C1 H27742362A071 H277423691EA2 H27742377EE04 H277423823A61 H277423832BE8 H27742396659D H277424050C1B H277424072F09 H277424242E22 H277424253FAB H277424260D30 H27742428E44E H27742429F5C7 H27742439EC1F H2847032948F1 H28470375FC25 H284703930303 H28470409F744 H2847041707E2 H28470428D57D H284704444BC1 H284704647871 H284704828757 H284705573A5E H28470582DD8B H28470601CEB4 H28470617B25A H284706438AC6 H284706582DCD H284706832366 H284707019468 H28470716F90F H28470731BE00 H28470747963E H28470760D131 H28470776ADDF H28470810D6FE H28470823CE0D H284708493587 H284708609BF6 H28470998CEAA H284710122F95 H284710312EBE H2847105248F5 H284710727B45 H28471086BEA9 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H28988040D47F H28988061F646 H28988088F197 H28988102CAD1 H289881258DDE H28988146EB95 H28988170A4CB H2898819478FF H289892188F8C H2898923744CB H289892615F45 H28989282F7CE H289892959AA9 H289894386AE5 H28989444ED81 H28989445FC08 H28989446CE93 H28989447DF1A H289894910A54 H289895081A51 H28989535EBDC H28989555BF0C H28989567B676 H28989589C518 H289896142681 H28989639CED4 H289896602DAD H28989684F199 H289897366CFF H289897550AB4 H289898042F42 H289898214B5F H28989834052A H289898603DB6 H28989883953D H28989908BFF2 H2898992774B5 H28989959D0C3 H28989975291F H28989993D639 H289943681893 H289944252813 H289944547492 H289944722214 H289944880E86 H28994497EFA9 H289945705BDA H289945741DFE H28994578D792 H28994583EA89 H28994597B575 H2899460875FE H28994621DB8F H28994645C97B H28994660AD66 H28994679297F H289946964B98 H28994710BAB2 H289947907472 H28994811E1FC H28994842ADDF H28994866D84B H289948793964 H289948974A0A H28994927F47E H28994951DC40 H289949668297 H289949834F2A H2899500033D4 H28995012091E H289950244640 H289950354E11 H28995058C124 H2899507438F8 H28997211B74B H28997234D356 H28997260EBCA H28997272D100 H28...

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Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

US Nationwide. Global Distribution.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Jun 14, 2023
Recall initiation date
May 1, 2023
Center classification date
Jun 2, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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