Recall Z-1289-2023— Philips Respironics, Inc.
Class I · Ongoing
Class I FDA medical device recall by Philips Respironics, Inc., initiated 2023-03-01. It names one FDA 510(k) clearance: K181170. Product: Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B. Reason: The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen..
- Recalling firm
- Philips Respironics, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-03-01
- 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 Universal Portable Electric Ventilator, Model Number DS2000X11B
Reason for recall
The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.
Data sourced from openFDA. This site is unofficial and independent of the FDA.