BEUDAMED
    FDA Recall Open, Classified

    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;

    Recall: Z-2942-2024 · Initiated July 16, 2024

    Recall

    Recall Number
    Z-2942-2024
    Event Number
    95078
    Firm
    Philips Respironics, Inc.
    FEI Number
    2518422
    Product Code
    NOU
    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 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.

    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