Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo,

FDA device recall Z-2942-2024 · posted 2024-09-05 · Open, Classified

Recall details

Recalling firm

Philips Respironics, Inc.

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.

Action taken

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

Status

Open, Classified

Product code

NOU

Quantity affected

90,910 US; 56,273 ROW

Distribution

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,

Date initiated

2024-07-16

Date posted

2024-09-05

Location

Murrysville, PA

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