Trilogy Evo Universal Ventilator, Model No. DS2000X11B
Reported: September 11, 2024 Initiated: July 16, 2024 #Z-2943-2024
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.
Details
- Recalling Firm
- Philips Respironics, Inc.
- Units Affected
- 90,910 US; 56,273 ROW
- Distribution
- Worldwide distribution: US (nationwide) and OUS (foreign) countries of: AU, BD, BE, BG, BO, BR, BS, CH, CL, NL, CN, CO, CZ, DE, DK, FR, SE, GB, GF, GR, GT, HK, HR, HU, IE, IL, IN, IT, JP, KE, KW, LB, LT, MA, ME, MA, MT, MQ, MX, NO, NP, OM, PA, PE, PF, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SI, SK, SG, TH, TN, TR, TW, UA, YT, ZA and ZW.
- Location
- Murrysville, PA
Frequently Asked Questions
What product was recalled? ▼
Trilogy Evo Universal Ventilator, Model No. DS2000X11B. Recalled by Philips Respironics, Inc.. Units affected: 90,910 US; 56,273 ROW.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 11, 2024. Severity: Critical. Recall number: Z-2943-2024.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11