FDA Device recall Z-1289-2023

Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B

FDA Device
Class I
ongoing
Published 2023-04-12

On 2023-04-12 the FDA classified a Class I recall of Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B by Philips Respironics, citing 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 inte….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1289-2023
Classification	Class I
Status	ongoing
Initiated	2023-03-01
Published	2023-04-12
Last updated	2026-09-13 11:56 UTC
Company	Philips Respironics
Distribution	US

Product

Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B

Reason

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.

Identifiers

code_info	Model number: DS2000X11B, UDI-DI: 606959052000. Serial Numbers: H27736231F4BE, H277362379188, H27736246CD09, H… 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, H2

code_info

Model number: DS2000X11B, UDI-DI: 606959052000. Serial Numbers: H27736231F4BE, H277362379188, H27736246CD09, H…

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, H2

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1289-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.