Recall Z-1504-2024— Philips Respironics, Inc.
Class I · Ongoing
Class I FDA medical device recall by Philips Respironics, Inc., initiated 2024-03-19. It names one FDA 510(k) clearance: K181170. Product: Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.. Reason: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power..
- Recalling firm
- Philips Respironics, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-03-19
- Firm location
- Murrysville, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Reason for recall
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Data sourced from openFDA. This site is unofficial and independent of the FDA.