FDAFDA · Alimentos y medicamentos·N.º oficial Z-0493-2022

Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg.

Publicado el 2 de febrero de 2022 · Inicio del retiro: 22 de diciembre de 2021

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante: Philips Respironics, Inc.
Distribuidor: Worldwide Distribution: Distributed to the following US states: AR, CO, FL, IA, IL, KY, LA, MI, MT, OH, PA, TN, TX, UT, VA, WV, and WY; and Distributed to the following foreign countries: Argentina, Brazil, Romania, and Netherlands.
Lote: UDI-DI: 00606959051942 (USA); 00606959055483 (Korea) Product Identifier (Serial Numbers): H312385987BBD H31238613E4CA H31241259862E H31241349C52A H312413624849 H31246293D7F5 H29069399D107 H29669926A6D8 H296700951ED2 H296701855DD6 H29674238FF13 H296742474AEC H31220934079E H312209523678 H31220968B34A H280964980B5B H2967018997BA H296723150600 H2967242692F6 H296742253D2E H29674250278B H312207401CA9 H312208968320 H312209071F6D H31220910720A H3122091706B5 H31220928D42A H29670062E9A5 H29670177FD0C H2967017805FB H29672401D5F9 H29672403F6EB H29674270143B H297843621AFA H312413504133 H312209241E46 H312209466984 H2967239902AC H31220819B517 H312208463358 H31220879E1C7 H3122089792A9 H3122092149EB H3122086600E8 H3122093262A8 H31220939DC7B H31220950156A H312209603F02 H31220996D9FC H3122081028D6 H3122083329FD H31220840566E H312208540992 H3122086065DE H31220844104A H312209006BD2 H31220908E79A H3122093041BA H311986468D0A H31198653C37F H31198703E71B H311987378B57 H31199129B193 H311991651C9F H312002723AE6 H3120033750F7 H3120041817B5 H31200649CD3C H3120080642B0 H312008165B68 H312010168111 H3120105192CE H312010580F0F H31201122B781 H31201136E87D H31201153EB00 H31201160F3F3 H31206064B82A H31238478BB71 H31238600CF89 H312386149075 H31238626990F H312413562405 H312413642D7F H312413653CF6 H312413671FE4 H312413707283 H31245188BA57 H31246258C086 H3124630068AA H29670055B772 H29670089CD66 H29670120F70B H29670195440E H296723243DE1 H29672330621D H2967240593DD H29672456DFFE H296742224991 H29784208BBAC H312209272CDD H312209400CB2 H31192401F7C3 H311924097B8B H311924178B2D H3119242493DE H31192433FEB9 H31192470AB42 H3119247399D9 H31192474ED66 H31216909A045 H31216910245C H3121691573F1 H31217046BF77 H312170485609 H31217092492B H31217104A1D9 H312171178A9A H31217131DC1C H31217132EE87 H312171348BB1 H312171359A38 H31217137B92A H312171395054 H31217140809D H31217142A38F H31217146E5AB H312171491D5C H312171509945 H31217152BA57 H31217154DF61 H31217156FC73 H31217158150D H312171590484 H31217161A2A4 H3121716381B6 H31217165E480 H31217167C792 H312171683F65 H312171692EEC H31217171BB7C H3121717289E7 H31217173986E H31217174ECD1 H31217175FD58 H3121717826BD H312171793734 H31220719FFD0 H312207226B6B H312207237AE2 H312207240E5D H312207262D4F H312207314028 H31220733633A H312207341785 H31220737251E H312207432E32 H312207454B04 H312207476816 H312207522663 H3122075552DC H3122075771CE H31220881EE47 H3122095761D5 H312209630D99 H312209665A34 H31220997C875 H312208354CCB H312208376FD9 H31220842757C H31220849CBAF H312208573B09 H312208671161 H31220868E996 H312208743A22 H3122087708B9 H312209035949 H3121691135D5 H31217033A5D2 H312171480CD5 H31217176CFC3 H31220738DDE9 H312208175C69 H312208299F7F H31220869F81F H31220883CD55 H31220954534E H3119904310C5 H31200467A24A H31200537862E H312006146861 H312008735815 H31200991BBCB H312012037ADC H312022674DE5 H312058755374 H31207455FC11 H31208096B6B2 H31217042F953 H312170906A39 H31217144C6B9 H31217145D730 H31217166D61B H31217177DE4A H31220804772A H31220808BD46 H3122082002BE H3120592203AF H31217103D566 H31217147F422 H312208277601 H312208310AEF H312208526CA4 H31220919EFCB H312209983082 H31226199AC53 H3122724163BC H312272425127 H31227263731E H312272727B4F H31227280DB95 H31227293F0D6 H312273127543 H3122731722EE H31227319CB90 H312273252B94 H31227329E1F8 H31227335324C H31227386E47F H31227397EC2E H312274194795 H31227534F51C H31227562EE92 H3122756841C8 H31227577A0E7 H31227587232F H312276043010 H312276124CFE H31227623771F H3122764323CF H312276511905 H312276712AB5 H31227679A6FD H31227697D593 H312277031E73 H31227708A0A0 H31227719A8F1 H3122772548F5 H3122773663B6 H312277451C25 H31227758DE18 H31227769E5F9 H31227777155F H31227784A40C H31227785B585 H31227786871E H312277879697 H312278315DCE H31227838C00F H3122784333D4 H312278499C8E H312278702B27 H31227884EECB H31227908B0BB H31227914630F H312279389AD3 H312279436908 H3122796179AA H312279671C9C H3122797437DF H31227985A59E H31228003208F H312280089E5C H312280155C61 H31228023133F H3122803129F5 H3122804522D9 H312280524FBE H312280651169 H31
Clasificación de riesgo: Class I
Área (FDA): device
País: United States

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