Reported Sep 11, 2024 · Ongoing

Trilogy Evo Universal Ventilator, Model No. DS2000X11B

Philips Respironics, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Respironics, Inc. · 1001 Murry Ridge Ln · Murrysville, PA · 15668-8517

Is this the product you have?

  • Trilogy Evo Universal Ventilator, Model No. DS2000X11B
Lot codes and dates
  • UDI-DI606959052000 US Serial Numbers

    2,326 of 2,326 codes

    • H28984740CF4E
    • H28984800E2E9
    • H3069350132A0
    • H30753614E0AA
    • H30789237223A
    • H307892401B8D
    • H307892445DA9
    • H307892476F32
    • H307892646E19
    • H307892657F90
    • H30789268A475
    • H30789269B5FC
    • H30803946EC1A
    • H308039813105
    • H308040536950
    • H308040753FD6
    • H30804091E3E2
    • H30804129D1DE
    • H3081539229E2
    • H3081768676D5
    • H30817950E95C
    • H3081837986AE
    • H30828473B83D
    • H30828515D307
    • H30835691344C
    • H308357380E21
    • H308357448945
    • H30835753E422
    • H30835756B38F
    • H30835772C61B
    • H3083577791B6
    • H308357786941
    • H30835794393D
    • H30835853AEE5
    • H3083585901BF
    • H30835863848D
    • H30835900B81A
    • H30882857F80C
    • H308829934D54
    • H308830388E52
    • H308830607CA2
    • H30883068F0EA
    • H3088307532D7
    • H308830868384
    • H30883094B94E
    • H30883120411E
    • H30883128CD56
    • H30883139C507
    • H308831511D9F
    • H3088315991D7
    • H308831703FA6
    • H30883178B3EE
    • H308831883026
    • H308832009DCA
    • H308862087FD5
    • H308862179EFA
    • H30886226A51B
    • H30886231C87C
    • H308862418574
    • H30886253BFBE
Amount recalled
90,910 US; 56,273 ROW

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:59 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.