Reported Jan 18, 2023 · Ongoing
Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800,…
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?
Philips Trilogy 200 VentilatorModel Numbers 1040005U10400051040005BU1040005BCA1032800BCA1032800KO10328001032800R1032804TPR1032804BR1032804TPV1032804B
- Lot codes and dates
- UDI
0060695942915400606959429208006069594291470060695942918500606959429710006069594296110060695942947500606959429260006069590339860060695903399300606959429444
- Serial Numbers
538 of 538 codes
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
- UDI
- Amount recalled
- 537 devices
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.
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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