Trilogy Evo Ventilator Repair Kit Recalled for Degrading Foam Material
Philips Respironics recalled 205 Trilogy Evo ventilator repair kits containing non-conforming foam material that may degrade into particles potentially inhaled or ingested by users. The affected kits were distributed in the US and internationally.
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 an FDA Class I recall of a medical device (ventilator repair kit) where non-conforming foam material may degrade into inhaled or ingested particles. Per the severity rubric, FDA Class I recalls require a minimum severity score of 4, despite no reported illnesses, due to the serious potential for harm.
Plain-English summary
Philips Respironics is recalling 205 Trilogy Evo Repair Kits (RP-Trilogy Evo Muffler Assembly, Material Number 1135257, Lot Numbers 210414 through 210524) distributed in the United States and internationally. The ventilator is intended for pediatric through adult patients weighing at least 2.5 kg and provides continuous or intermittent positive pressure ventilation.
A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) foam, a non-conforming material, in the devices and repair kits. This PE-PUR foam may degrade into particles that could enter the device's air pathway and be inhaled or ingested by users. Additionally, the foam may off-gas certain chemicals during initial device use. Foam degradation may be exacerbated by use of unapproved cleaning methods such as ozone cleaners.
The recalled kits were distributed to the following US states: Arkansas, Colorado, Florida, Iowa, Illinois, Kentucky, Louisiana, Michigan, Montana, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, West Virginia, and Wyoming. International distribution included Argentina, Brazil, Romania, and the Netherlands.
Contact Philips Respironics or your device supplier for information regarding this recall.
The recalled product
- Product
- Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric…
- Manufacturer
- Philips Respironics, Inc.
- Affected units
- 205
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers 210414 - 210524
Distribution
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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Same hazard · foam degradation
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