Reported Jul 12, 2023 · Ongoing

Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use

Philips Respironics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
Lot codes and dates
  • Material No. KR2110X15B
  • GTIN

    1,582 of 1,582 codes

    • 00606959055483
    • Serial No. H30665832F44A
    • H3066588656C6
    • H306658946C0C
    • H30665905F041
    • H306659391045
    • H30665956BC62
    • H30665965A491
    • H306659871D93
    • H30665993426F
    • H306660257A22
    • H306660321745
    • H30666039A996
    • H306660506087
    • H30666058ECCF
    • H306660637874
    • H30666068C6A7
    • H3066608496DB
    • H30666098456F
    • H3066612703EC
    • H306661402383
    • H30666141320A
    • H306661420091
    • H306661431118
    • H3066614646B5
    • H30666147573C
    • H306661601033
    • H3066617009EB
    • H306661755E46
    • H30670227AC56
    • H30670253A77A
    • H306702638D12
    • H306702692248
    • H30670276C367
    • H3067028463BD
    • H30670298B009
    • H30670303831E
    • H30670315FFF0
    • H30670327F68A
    • H30670336FEDB
    • H306703485AAD
    • H306703548919
    • H30670361F4DC
    • H306703697894
    • H306703834DDE
    • H30670392458F
    • H306704030F1B
    • H3067041135D1
    • H306704244814
    • H306704376357
    • H306704441CC4
    • H30670454051C
    • H306704606950
    • H3067047615BE
    • H30670484B564
    • H306704887F08
    • H3067051438A0
    • H30670519E345
    • H306705236677
    • H306705250341
Amount recalled
1,581 units

Why it was recalled

There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".

This product could cause temporary or reversible health problems — stop using it.

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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, 5:37 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.