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Open, Classified

Trilogy Evo Universal Ventilator, Model No. DS2000X11B

FDA Recall Z-2943-2024 · Posted 2024-09-05

Recalling FirmPhilips Respironics, Inc.
Recall StatusOpen, Classified
Product CodeCBK
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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