Philips Trilogy 100 Ventilator Foam May Separate and Block Air Inlet
Silicone sound abatement foam in some Philips Trilogy 100 ventilators may separate and block the air inlet, potentially reducing delivered therapy volume or pressure and causing device alarms.
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: This is a Class I FDA recall, which mandates a minimum severity score of 4. Although no illnesses or injuries have been reported, the potential for failure in therapy delivery in ventilator-dependent patients represents a serious safety risk.
Plain-English summary
This is a Class I recall by the FDA concerning the Philips Trilogy 100 Ventilator, manufactured by Philips Respironics, Inc. Approximately 20,807 units are affected and have been distributed nationwide in the US and globally to Australia, Brazil, Canada, China, Germany, Japan, Korea, and Latin America.
The defect involves the replacement silicone sound abatement foam component. This foam may separate from the plastic backing to which it is attached. If separation occurs, the foam could potentially block the device's air inlet.
A blocked air inlet could result in a reduction of the therapy volume or pressure delivered to the patient and may cause the device to activate its alarm.
The recalled product
- Product
- Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655TPV, AU1054096, AU1054096B, 1054096B, 1054097, BR1054096, LA1054096, CN1054096, KO1054096…
- Manufacturer
- Philips Respironics, Inc.
- Affected units
- 20,807
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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