Reported Feb 26, 2020 · Terminated
LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is intended for pediatric through adult patients…
Philips Respironics, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Respironics, Inc. · 1001 Murry Ridge Ln · Murrysville, PA · 15668-8517
Is this the product you have?
- LifeVent EVO Ventilator, 02 -
- Model NumberSP2100X26B 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
- Lot codes and dates
- Model/Material NumberSP2100X26B
- Serial Numbers
H25538574D9D9H256917933B78H2569193868C0H2569196907F1H25691987749FH256920522A99H2569224829A3H256924542CCEH256925062BB8H25692591881FH25692661E4B3H25692712C1FCH25692910F2F5H25692952B687H256930400CE8H25693118A4C4H2569421090C9H256943094E0CH25755370F165H25755371E0ECH25755372D277H25769443EF6BH2576945959E9H2576949608BEH25769512DA86H25769515AE39H257695178D2BH257699654692H25772204E13C
- Amount recalled
- 29
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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