Philips Respironics, Inc.: Device Recall

Recall #Z-2943-2024 · 07/16/2024

Class I: Dangerous

Recall Details

Recall Number
Z-2943-2024
Classification
Class I
Product Type
Device
Recalling Firm
Philips Respironics, Inc.
Status
Ongoing
Date Initiated
07/16/2024
Location
Murrysville, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
90,910 US; 56,273 ROW

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.

Product Description

Trilogy Evo Universal Ventilator, Model No. DS2000X11B

Distribution Pattern

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.

Other Recalls by Philips Respironics, Inc.

View all recalls by Philips Respironics, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.