Reported Jun 14, 2023 · Ongoing
Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B,…
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 EvoGarbin Evoand Aeris EVOModel Numbers DS2110X11BIN2110X15BJP2110X16BAU2110X15BLA2110X15BCA2110X12BBR2110X18BKR2110X15BIA2110X15BFP2110X10FR2110X14BND2110X15BIT2110X21BES2110X15BDE2110X13BBL2110X15BGB2110X15BEU2110X15BEE2110X15BLD2110X23Band VT2110X24B
- Lot codes and dates
- UDI-DI
606959051942606959051959606959051973606959051980606959055452606959052307606959055476606959055483606959055490606959062092606959055506606959055513606959055421606959054080606959054110606959055520606959054127606959054981606959055544606959057432606959062962
- Serial Numbers
2,308 of 2,308 codes
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
- UDI-DI
- Amount recalled
- 57,395 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.
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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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