FDA Device recall Z-1288-2023

Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15…

FDA Device
Class I
ongoing
Published 2023-04-12

On 2023-04-12 the FDA classified a Class I recall of Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15… 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-1288-2023
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 EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15B, IA2200X15B, FR2200X14B, ND2200X15B, IT2200X21B, ES2200X15B, DE2200X13B, BL2200X15B, GB2200X15B, EU2200X15B, EU2200X19, EE2200X15B, TR2200X15B, RU2200X15B

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	UDI-DI: 606959052017, 606959056497, 606959061033, 606959052321, 606959058613, 606959058620, 606959058644, 606… UDI-DI: 606959052017, 606959056497, 606959061033, 606959052321, 606959058613, 606959058620, 606959058644, 606959058668, 606959058675, 606959058682, 606959058705, 606959058798, 606959052000. UDI-DI, Model number: Serial numbers 606959052017, DS2200X11B: H27990931E388, H27990933C09A, H27990934B425, H279909369737, H28068115E37D, H28068117C06F, H28086487E130, H280912810EBA, H28091329255E, H280914614273, H28091549A757, H28091634DEDE, H28091674B9BE, H280918082EC1, H280918779B3E, H28091945C898, H28092332A798, H2809235587F7, H28092419A6FE, H280924344EAB, H280924473138, H28092465219A, H280924717E66, H28092478E3A7, H28092499683E, H2809251427C7, H280925341477, H280925522591, H280925631E70, H28092614C8A3, H28096497F3AC, H280964991AD2, H280965000AD7, H280965011B5E, H2809650229C5, H28096503384C, H280965044CF3, H280965055D7A, H280965066FE1, H280965077E68, H28270803E547, H28270834BB90, H28270854EF40, H28270873A84F, H282708832B87, H28270

code_info

UDI-DI: 606959052017, 606959056497, 606959061033, 606959052321, 606959058613, 606959058620, 606959058644, 606…

UDI-DI: 606959052017, 606959056497, 606959061033, 606959052321, 606959058613, 606959058620, 606959058644, 606959058668, 606959058675, 606959058682, 606959058705, 606959058798, 606959052000. UDI-DI, Model number: Serial numbers 606959052017, DS2200X11B: H27990931E388, H27990933C09A, H27990934B425, H279909369737, H28068115E37D, H28068117C06F, H28086487E130, H280912810EBA, H28091329255E, H280914614273, H28091549A757, H28091634DEDE, H28091674B9BE, H280918082EC1, H280918779B3E, H28091945C898, H28092332A798, H2809235587F7, H28092419A6FE, H280924344EAB, H280924473138, H28092465219A, H280924717E66, H28092478E3A7, H28092499683E, H2809251427C7, H280925341477, H280925522591, H280925631E70, H28092614C8A3, H28096497F3AC, H280964991AD2, H280965000AD7, H280965011B5E, H2809650229C5, H28096503384C, H280965044CF3, H280965055D7A, H280965066FE1, H280965077E68, H28270803E547, H28270834BB90, H28270854EF40, H28270873A84F, H282708832B87, H28270

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-1288-2023%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.