BEUDAMED
    FDA Recall Open, Classified

    Trilogy Evo Universal Ventilator, Model No. DS2000X11B

    Recall: Z-2943-2024 · Initiated July 16, 2024

    Recall

    Recall Number
    Z-2943-2024
    Event Number
    95078
    Firm
    Philips Respironics, Inc.
    FEI Number
    2518422
    Product Code
    CBK
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    July 16, 2024
    Posted
    September 5, 2024
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8517

    Description

    Trilogy Evo Universal Ventilator, Model No. DS2000X11B

    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.

    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.

    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, 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.

    Quantity

    90,910 US; 56,273 ROW