RecallRadar

FDA Device recall Z-2942-2024

Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300

On 2024-09-11 the FDA classified a Class I recall of Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300 by Philips Respironics, citing firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier rec….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2942-2024
ClassificationClass I
Statusongoing
Initiated2024-07-16
Published2024-09-11
Last updated2026-09-13 11:57 UTC
CompanyPhilips Respironics
DistributionUS

Product

Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B Trilogy Evo, O2, USA EV300; EE2200X15B Trilogy Evo, O2, Eastern Europe EV300; ES2200X15B Trilogy Evo, O2, Spain EV300; EU2200X15B Trilogy Evo, O2, EU EV300; FR2200X14B Trilogy Evo, O2, France EV300; FX2200X15B Trilogy Evo, O2, INT EV300; GB2200X15B Trilogy Evo, O2, Great Britain EV300; IN2200X15B Trilogy Evo, O2, INTL EV300; IT2200X21B Trilogy Evo, O2, Italy EV300; KR2200X15B Trilogy Evo, O2, Korea EV300; ND2200X15B Trilogy Evo, O2, Nordics EV300; TR2200X15B Trilogy Evo, O2, Turkey EV300;

Reason

Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.

Identifiers

code_info
Model / UDI-DI: Trilogy Evo, O2, Benelux EV300 606959058668; Trilogy Evo, O2, Brazil EV300 606959058583; Trilogy Evo, O…Model / UDI-DI: Trilogy Evo, O2, Benelux EV300 606959058668; Trilogy Evo, O2, Brazil EV300 606959058583; Trilogy Evo, O2, Canada EV300 606959052321; Trilogy Evo, O2, Germany EV300 606959058651; Trilogy Evo, O2, USA EV300 606959052017; Trilogy Evo, O2, USA EV300 606959052017; Trilogy Evo, O2, Eastern Europe EV300 606959058705; Trilogy Evo, O2, Spain EV300 606959058644; Trilogy Evo, O2, EU EV300 606959058682; Trilogy Evo, O2, France EV300 606959058613; Trilogy Evo, O2, INT EV300 606959061033; Trilogy Evo, O2, Great Britain EV300 606959058675; Trilogy Evo, O2, INTL EV300 606959056497; Trilogy Evo, O2, Italy EV300 606959058637; Trilogy Evo, O2, Korea EV300 606959058590; Trilogy Evo, O2, Nordics EV300 606959058620; Trilogy Evo, O2, Turkey EV300 606959058798; US Serial Numbers: H284098132DDA H284098302CF1 H33497881D1CB H33497883F2D9 H33497890D99A H334979140BA2 H358294978811 H35830133F8DF H35830506E67B H35830557894A H358305795384 H35830750484D H29713003B682 H297748223EC0 H28409798170E H284

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2942-2024%22

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