Philips Respironics, Inc.: Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use

Hazard

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

Details from the source

Reason for recall: There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive". Distribution: Foreign Distribution: Korea. Quantity: 1,581 units Lot/code info: Material No. KR2110X15B, GTIN: 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, H306705326E26, H3067054332A7, H306705455791, H30670546650A, H306705567CD2, H306705630117, H30670568BFC4, H30670584EFB8, H30670590B044, H30670597C4FB, H3067061091E0, H30670615C64D, H30670624FDAC, H30670625EC25, H306706292649, H30670644A97C, H306706587AC8, H30670667A857, H306706784978, H306706837463, H30670688CAB0, H30670695088D, H30670703E07F, H306707094F25, H30670720E154, H30670725B6F9, H30670734BEA8, H30670741A40D, H30670765D199, H306707718E65, H3067077813A4, H306707854B89, H3067079226EE, H306707977143, H30670802BB31, H306708119072, H30670861DD7A, H3

UPC codes

00606959055483

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.