Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B 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.
Enforcement
- Recall Number
- Z-0944-2020
- Event ID
- 84406
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Respironics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 26, 2020
- Initiation Date
- November 19, 2019
- Classification Date
- February 14, 2020
- Termination Date
- March 31, 2021
- Address
- 1001 Murry Ridge Ln, Murrysville, PA, 15668-8517, United States
Description
Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B 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.
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.
Model/Material Number: DE2110X13B Serial Numbers: H23708996882F, H24371560D579, H255384963A07, H2579305546B6, H2579306309E8, H23616736C469, H236241588BA4, H23626795164E, H23626844FD78, H236271027F8B, H236283633D93, H257930373174, H25793039D80A, H257930621861, H257930656CDE, H25793068B73B, H24740249E6D6, H24740326102D, H2474037887EB, H24740441BC47, H24740484424A, H24740639C8BF, H247408214D34, H247465944AD4, H247498926264, H24749940ABD2, H24750005F526, H247500934708, H24750114A7AB, H248213036E9A, H2497582673B2,
US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ
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