Reported Apr 12, 2023 · Ongoing
Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19,…
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 O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, PP2100X10, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, BL2100X15B, GB2100X15B, EU2100X15B, EU2100X19, EE2100X15B, TR2100X15B, UDS2100X11B, RDS2100X11B, and SP2100X26B
- Lot codes and dates
- UDI-DI
606959051997606959054059606959055575606959061019606959055599606959055636606959062085606959055643606959055650606959055438606959054097606959054103606959055674606959055681606959055698. UDI-DI
- Model NumberSerial numbers. 606959054103
- DE2100X13B
635 of 635 codes
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
- Model NumberSerial numbers. 606959051997
- DS2100X11B
H26581728CE54H27737603821EH277379248FD6H277424271CB9H277424352673H277424447AF2H277424474869H27742449A117H277424531795. UDI-DI
- Model Number
61 of 61 codes
Serial numbers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
- Model NumberSerial numbers. 606959054097
- ES2100X15B
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
- Model NumberSerial numbers. 606959055674
- EU2100X15B
248 of 248 codes
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
- Model NumberSerial numbers. 606959055681
- EU2100X19
H8001030650BDH80010308B9C3H80019091E51DH80019093C60F. UDI-DI
- Model NumberSerial numbers. 606959062085
- FP2100X10
H80017061C897H80017062FA0CH80017066BC28H80017067ADA1H800170685556H800182181F1FH800182190E96H80018227CD80H8001824861A7H80018249702EH80018251E5BE. UDI-DI
- Model NumberSerial numbers. 606959055643
- FR2100X14B
H2746649868FFH2747923076A3H274792732358H2747936052C7H27479461CF4B. UDI-DI
- Model NumberSerial numbers. 606959061019
- FX2100X15B
1,105 of 1,105 codes
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
- UDI-DI
- Amount recalled
- 62,826 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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