Philips Respironics, Inc. Recall 94263
Description: Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Philips Respironics, Inc. Recall 94263 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1505-2024 |
| Event ID | 94263 |
| Event Description | Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. |
| Product Type | Devices |
| 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. |
| Quantity | 9,999 units |
| Recall Reason | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. |
| Device Classification | 20240424 |
| Device Code Info | Model No. DS2000X11B; UDI-DI: 606959052000; All units except those with software version 1.05.06.00. |
| Center Classification Date | 20240417 |
| Recall Initiation Date | 20240319 |
| Recalling Firm | Philips Respironics, Inc. |
| Initial Notification | Letter |
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