PlainRecalls
FDA Devices Critical Class I Ongoing

Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

Reported: April 24, 2024 Initiated: March 19, 2024 #Z-1503-2024

Product Description

Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

Reason for Recall

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

Details

Recalling Firm
Philips Respironics, Inc.
Units Affected
789 units
Distribution
Domestic: Nationwide Distribution; Foreign: AE, AR, AT, AU, BD, BE, BG, 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, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PR, PT, PY, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, US, UY, VN, YT, ZA, ZW.
Location
Murrysville, PA

Frequently Asked Questions

What product was recalled?
Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.. Recalled by Philips Respironics, Inc.. Units affected: 789 units.
Why was this product recalled?
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 24, 2024. Severity: Critical. Recall number: Z-1503-2024.