Recall Z-1501-2024— Philips Respironics, Inc.

Name: FDA recall Z-1501-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-19

Class I · Ongoing

Class I FDA medical device recall by Philips Respironics, Inc., initiated 2024-03-19. It names one FDA 510(k) clearance: K181166. Product: LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US). 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 record

K181166 — Trilogy EvoRespironics, Inc.·cleared 2019-07-18

K-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

LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)

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.