Philips Respironics, Inc. Recall: Trilogy EVO Ventilator, France - Model Number: FR2110X14
Philips Respironics, Inc. Recall: Trilogy EVO Ventilator, France - Model Number: FR2110X14 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Philips Respironics, Inc.; Product: Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is intended for pediatric through adult p
| Recalling firm | Philips Respironics, Inc. |
|---|---|
| Product | Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. |
| Reason for recall | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Terminated |
| Distribution | US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ |
| Recall initiated | 20191119 |
| Recall number | Z-0949-2020 |
| Category | device |
| State | PA |
| Country | United States |
$29/mo
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