Philips Respironics, Inc. recalls Trilogy Evo Universal Ventilator, Model No. DS2000X11B

Recall date

July 16, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2943-2024

FDA classification

Class I

Brand / firm

Philips Respironics, Inc.

Sold / distributed

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,…

Why it was 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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Trilogy Evo Universal Ventilator, Model No. DS2000X11B