Philips Respironics, Inc.: Device Recall

Recall #Z-0290-2025 · 10/07/2024

Class I: Dangerous

Recall Details

Recall Number
Z-0290-2025
Classification
Class I
Product Type
Device
Recalling Firm
Philips Respironics, Inc.
Status
Ongoing
Date Initiated
10/07/2024
Location
Murrysville, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24,249 units

Reason for Recall

Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.

Product Description

Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GF, GI, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JE, JO, JP, KE, KR, KW, LB, LT, LY, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, TZ, UA, UY, VN, YT, ZA, ZW.

Other Recalls by Philips Respironics, Inc.

View all recalls by Philips Respironics, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.