Philips Trilogy 100 and 200 Ventilators Recalled for Foam Separation Risk
Silicone foam in some Philips Trilogy 100 and 200 ventilators may separate and block the air inlet, potentially reducing therapy delivery. This is an FDA Class I recall.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recalls require a minimum severity score of 4. Although no illnesses or injuries have been reported, the potential for silicone foam to block the air inlet of a ventilator presents a significant risk to patients dependent on these life-support devices.
Plain-English summary
Philips Respironics is recalling some Trilogy 100 and Trilogy 200 ventilators. The silicone sound abatement foam installed in these devices may separate from the plastic backing to which it is attached. If separation occurs, the foam could potentially block the air inlet.
A blocked air inlet could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm. This affects specific serial numbers across multiple model variations of the Trilogy 100 and Trilogy 200 device lines.
These ventilators were distributed nationwide in the United States and globally to Australia, Brazil, Canada, China, Germany, Japan, Korea, and Latin America, totaling 537 devices. Patients using affected devices should contact Philips Respironics for guidance on replacement or corrective action.
The recalled product
- Product
- Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 537
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Philips Respironics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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