Reported Apr 12, 2023 · Ongoing
Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B
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?
- Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B
- Lot codes and dates
- Model numberDS2000X11B
- UDI-DI606959052000
- Serial Numbers
2,034 of 2,034 codes
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
- Amount recalled
- 62826 total devices
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Stop using this product now
The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.
Using this product could cause serious injury, illness or death — stop using it now.
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