Philips Respironics, Inc.: Device Recall
Recall #Z-0292-2025 · 10/07/2024
Recall Details
- Recall Number
- Z-0292-2025
- 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
- 9,999 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 Universal Ventilator. Model Number DS2000X11B. 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.
- Class II: Risk 10/07/2025
- Class I: Dangerous 06/30/2025
- Class I: Dangerous 06/30/2025
- Class I: Dangerous 06/30/2025
- Class I: Dangerous 05/09/2025