Trilogy Evo Ventilator Recalled for Foam Degradation Risk
Philips Respironics recalls 473 Trilogy Evo ventilators due to non-conforming foam that may degrade and release particles. Affected patients risk inhaling or ingesting foam particles and chemicals during device use.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4 per the severity rubric. Although no illnesses or injuries have been reported to date, the defective foam creates a documented inhalation and ingestion hazard for ventilator-dependent patients.
Plain-English summary
Philips Respironics is recalling 473 Trilogy Evo ventilators due to defective sound-abatement foam supplied by a vendor. These mechanical ventilation devices are intended for pediatric through adult patients.
The non-conforming polyester-based polyurethane (PE-PUR) foam may degrade into particles that enter the device's air pathway and could be inhaled or ingested by users. The foam may also off-gas chemicals during initial device use. Foam degradation may be accelerated by unapproved cleaning methods, such as ozone cleaners.
The affected devices were distributed worldwide, including to multiple U.S. states and international locations. Patients currently using affected devices should contact Philips Respironics or their healthcare provider for information about inspection, repair, or replacement of their devices.
The recalled product
- Product
- Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) 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 through adul
- Manufacturer
- Philips Respironics, Inc.
- Hazard
- foam-degradation
- inhalation-hazard
- ingestion-hazard
- chemical-off-gassing
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)
- UDI-DI: 00606959051942 (USA)
Distribution
Distributed in 17 states:
- AR
- CO
- FL
- IA
- IL
- KY
- LA
- MI
- MT
- OH
- PA
- TN
- TX
- UT
- VA
- WV
- WY
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