Recall Z-2943-2024— Philips Respironics, Inc.
Class I · Ongoing
Class I FDA medical device recall by Philips Respironics, Inc., initiated 2024-07-16. It names one FDA 510(k) clearance: K181170. Product: Trilogy Evo Universal Ventilator, Model No. DS2000X11B. Reason: Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls..
- Recalling firm
- Philips Respironics, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-07-16
- 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 Ventilator, Model No. DS2000X11B
Reason for recall
Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
Data sourced from openFDA. This site is unofficial and independent of the FDA.