Reported Jun 14, 2023 · Ongoing
Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B,…
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 LifeVent EVO2Model Numbers DS2100X11BIN2100X15BIN2100X19FX2100X15BLA2100X15BIA2100X15BFP2100X10FR2100X14BND2100X15BIT2100X21BES2100X15BDE2100X13BEU2100X15BEU2100X19EE2100X15Band SP2100X26B
- Lot codes and dates
- UDI-DI
606959051997606959054059606959055575606959061019606959055599606959055636606959062085606959055643606959055650606959055438606959054097606959054103606959055674606959055681606959055698606959057456
- Serial Numbers
2,312 of 2,312 codes
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
- UDI-DI
- Amount recalled
- 21,520 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
- Nationwide
Why it was recalled
Stop using this product now
Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.
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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