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Open, Classified

Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy Evo O2, Germany DE2110X13B Trilogy Evo, Germany DS2100X11B Trilogy Evo, O2, USA DS2110X11B Trilogy Evo, USA DS2110X11B Trilogy Evo, USA EE2100X15B Trilogy Evo O2, Eastern Europe EE2110X15B Trilogy Evo, Eastern Europe ES2100X15B Trilogy Evo O2, Iberia ES2110X15B Trilogy Evo, Iberia EU2100X15B Trilogy Evo, O2, EU EU2100X19 Trilogy Evo, O2, EU (Non-BT) EU2110X15B Trilogy Evo, EU EU2110X19 Trilogy Evo, EU (Non-BT) FR2100X14B Trilogy Evo O2, France FR2110X14B Trilogy Evo, France FX2100X15B Trilogy Evo, O2, INT GB2110X15B Trilogy Evo, Great Britain IA2100X15B Trilogy Evo O2, India IA2110X15B Trilogy Evo, India IN2100X15B Trilogy Evo, O2, International IN2100X19 Trilogy Evo, O2, International (Non-BT) IN2110X15B Trilogy Evo, International IT2100X21B Trilogy Evo O2, Italy IT2110X21B Trilogy Evo, Italy JP2100X16B Trilogy Evo, O2, Japan JP2110X16B Trilogy Evo, Japan KR2110X15B Trilogy Evo, Korea LA2100X15B Trilogy Evo, O2, Latin America LA2110X15B Trilogy Evo, Latin America LD2110X23B Garbin Evo, Linde ND2100X15B Trilogy Evo O2, Nordics ND2110X15B Trilogy Evo, Nordics RDS2110X11B Trilogy Evo, USA-Rental SP2100X26B LifeVentEVO2 TR2110X15B Trilogy Evo, Turkey UDS2110X11B Trilogy Evo, USA-RECERT VT2110X24B Aeris EVO

FDA Recall Z-2944-2024 · Posted 2024-09-05

Recalling FirmPhilips Respironics, Inc.
Recall StatusOpen, Classified
Product CodeNOU
Date Initiated2024-07-16
Product Quantity90,910 US; 56,273 ROW

Reason for Recall

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.

Firm Action

On July 16, 2024, the firm began notifying customers through letters titled "URGENT Medical Device Correction" - UPDATE. Customers were informed of the release of mandatory software update version 1.05.10.00 and a User Manual addendum for the Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators. This letter outlines the safety issues addressed by this update, previously tracked through recalls RES 91832, 92048, 92515, 93609, and 94263. Issues include "Accuracy of Oxygen Delivery", "Environmental Contamination of Device Sensor", "Battery Depleted or Loss of Power Alarms Triggered", "Incomplete Contraindications Statement", and "Translation errors in the Korean, Traditional Chinese, and Spanish Instructions for Use manuals". Customers were instructed to immediately update the device software following instructions provided in the letter. The firm will follow up with customers to ensure devices have been updated. DME/Homecare users can access the software via the "My Philips for Professionals" website. Hospital users can access the software via In Center. If you have any questions, call 800-345-6443.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution: US (nationwide) and OUS (foreign) countries of: AU, BD, BE, BG, BO, BR, BS, CH, CL, NL, CN, CO, CZ, DE, DK, FR, SE, GB, GF, GR, GT, HK, HR, HU, IE, IL, IN, IT, JP, KE, KW, LB, LT, MA, ME, MA, MT, MQ, MX, NO, NP, OM, PA, PE, PF, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SI, SK, SG, TH, TN, TR, TW, UA, YT, ZA and ZW.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181170Trilogy Evo UniversalRespironics, Inc. · 2019-07-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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