Philips Respironics, Inc. 2023-01-18 Health critical FDA
Health · FDA · Recall #FDA-Z-0882-2023
Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B,… Recall
Issued January 18, 2023 · Philips Respironics, Inc.
In January 2023, Philips Respironics, Inc. recalled the Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B,…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Philips Respironics, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Philips Respironics, Inc.
- Category
- Health
- Recall date
- January 18, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide and Global Distribution to countries of: Australia, Brazil, Canada, China, Germany, Japan, Korea, and Latin America.
- Recall number
- FDA-Z-0882-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Philips Respironics, Inc. has 7 recalls in our database, including 7 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.