Philips Trilogy Evo ventilators recall: flow sensor fouling risk
Philips Respironics is recalling Trilogy Evo ventilators due to potential aerosol deposits on the internal flow sensor, which could cause inaccurate flow measurements during ventilation.
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: This is an FDA Class I recall, which establishes a minimum severity score of 4 per the rubric. No deaths, illnesses, or injuries are reported in the source text, but the FDA classification reflects the serious potential for harm from inaccurate flow measurements on a critical care ventilator.
Plain-English summary
Philips Respironics, Inc. is recalling Trilogy Evo ventilators in response to an FDA Class I safety notice. These devices are used for invasive and non-invasive ventilation of patients in institutional, home, and non-emergency transport settings.
When in-line nebulizers are configured in certain locations, aerosol deposits can accumulate on the device's internal flow sensor. This accumulation could cause inaccurate flow measurements, potentially affecting ventilation delivery to patients.
Approximately 82,800 units have been distributed worldwide, including throughout the United States and numerous international locations. Facilities and patients using affected devices should contact Philips Respironics for further information regarding this recall.
The recalled product
- Product
- Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110X15B, BL2110X15B, EU2110X15B, BR2110X18B, LA2110X15B, EE2110X15B, FR2110X14B, GB2110X15B, ND2110X15B, ES2110X15B, IA2110X15B, IT2110X21B, KR2110X15B, TR2110X15B
- Manufacturer
- Philips Respironics, Inc.
- Hazard
- aerosol-accumulation
- inaccurate-flow-measurement
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 (20)
- Model Number (UDI-DI Number): AU2110X15B (606959051980)
- BL2110X15B (606959055520)
- BR2110X18B (606959055476)
- CA2110X12B (606959052307)
- DE2110X13B (606959054110)
- DS2110X11B (606959051942)
- EE2110X15B (606959055544)
- ES2110X15B (606959054080)
- EU2110X15B (606959054981)
- EU2110X19 (606959055537)
- FP2110X10 (606959062092)
- FR2110X14B (606959055506)
- GB2110X15B (606959054127)
- IA2110X15B (606959055490)
- IN2110X15B (606959051959)
- IT2110X21B (606959055421)
- JP2110X16B (606959051973)
- KR2110X15B (606959055483)
- LA2110X15B (606959055452)
- ND2110X15B (606959055513)
Distribution
Distributed nationwide across the United States.
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