Philips Trilogy Evo respiratory devices recalled for missing contraindication statement
Philips recalled Trilogy Evo respiratory devices for missing contraindications in labeling. Devices lack warnings against use in pediatric patients under 10 kg and certain therapy modes, risking barotrauma and respiratory complications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: No illnesses or injuries reported. The missing contraindication statements create risk of serious respiratory harm (barotrauma, hypoventilation, hypercapnia, CO2 rebreathing) for contraindicated patients. This risk-of-harm scenario without reported injury meets the High severity criterion.
Plain-English summary
Philips Respironics recalled Trilogy Evo and Trilogy Evo O2 non-invasive ventilation devices globally due to missing contraindication statements in their labeling. The recall affects 100,126 units total: 54,691 units in the United States and 45,435 units distributed outside the United States.
The recalled devices lack required contraindications in their labeling. Specifically, the labeling does not state that the AVAPS-AE therapy mode is contraindicated for invasive use and for patients less than 10 kg, and that the AVAPS feature is contraindicated for patients less than 10 kg.
Using these devices in contraindicated patients could result in serious respiratory complications including barotrauma, hypoventilation, hypercapnia (excessive carbon dioxide buildup), and rebreathing of excessive CO2.
Patients and caregivers should consult their healthcare provider regarding the recalled device and their specific clinical situation. Healthcare providers should ensure these devices are not used in patients who fall under the stated contraindications.
The recalled product
- Product
- Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B EE2110X15B ES2100X15B ES2110X15B EU2100X15B EU2100X19 EU2110X15B FR2100X14B FR2110X14B FX2100X15B GB2110X15B IA2100X15B…
- Manufacturer
- Philips Respironics, Inc.
Distribution
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