FDAFDA · Alimentos y medicamentos·N.º oficial Z-1812-2024
BiPAP V30 Auto Ventilator, Part Number 1111178
Publicado el 29 de mayo de 2024 · Inicio del retiro: 26 de marzo de 2024
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
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Philips Respironics, Inc.
- Distribuidor
- Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, and Turkey.
- Lote
- UDI-DI 00606959049635 Serial Numbers N2068642229E4 N206864244CD2 N206864255D5B N206864277E49 N2068642886BE N206864299737 N2068643102A7 N20686432303C N2068643321B5 N20686434550A N206864354483 N206864367618 N206864376791 N206864389F66 N206864398EEF N206864405E26 N206864414FAF N206864427D34 N206864441802 N20686445098B N206864463B10 N206864472A99 N20686448D26E N20686449C3E7 N2068645047FE N206864515677 N2068645264EC N206864537565 N2068645401DA N206864551053 N2068645622C8 N206864573341 N20686458CBB6 N206864606D96 N206864617C1F N206864624E84 N206864635F0D N206864653A3B N2068646608A0 N2070799636A7 N20708029041F N20708103C229 N20708105A71F N2070811974AB N20708120C302 N20708137AE65 N20708141865B N20708147E36D N20713207A038 N20713212EE4D N207132184117 N20713222C425 N20713232DDFD N2071323872A7 N20713245E44A N207132582677 N20713270998F N207132810BCE N2071329445BB N2071329666A9 N207132977720 N207132988FD7 N207132999E5E N20713309139A N20713314D1A7 N207133190A42 N20713327C954 N207133328721 N2071333396A8 N2071335695D5 N20713363E810 N2071337594FE N20713377B7EC N2071338625AD N207133972DFC N207134088E16 N207134099F9F N207134145DA2 N207134212067 N2071342654D8 N207134375C89 N20713442462C N2071344357A5 N207134507CE6 N207134726C44 N2071347518FB N207134762A60 N20713478C31E N207134859B33 N205345571B7A N20534558E38D N20534559F204 N2053456045AD N2053456266BF N205345637736 N205345640389 N205345651200 N20534566209B N205345673112 N20534568C9E5 N20534569D86C N205345705C75 N205345714DFC N205345727F67 N205345736EEE N205345741A51 N205345750BD8 N206864266FC0 N20686430132E N206864436CBD N206864671929 N20686470744E N2068647165C7 N20686472575C N2068647346D5 N20686474326A N206864761178 N2068647700F1 N20686478F806 N20686479E98F N20686482D494 N20686483C51D N20686484B1A2 N20686485A02B N2068648692B0 N206864878339 N206864887BCE N20713231EF66 N207132955432 N207133019FD2 N207134740972 N207134773BE9 N20713479D297 N205345615424 N20686469F057 N20686480F786 N207082010E5F N20713263B2CC N206864642BB2 N20686468E1DE N20686481E60F N20713350F0E3 N207134737DCD N209923639729 N20992366C084 N2099236829FA N209923693873 N20992371ADE3 N20992376D95C N20992377C8D5 N2099237921AB N209923812E2B N209923920568 N2099239314E1 N2099239571D7 N20992396434C N20992398AA32 N20992399BBBB N209924043B43 N209924052ACA N2099240709D8 N2099241064BF N2099241247AD N209924153312 N209924171000 N20992418E8F7 N209924237C4C N20992425197A N209924262BE1 N20992430570F N20992432741D N209924336594 N20992434112B N209924401A07 N209924423915 N20992443289C N2099245003DF N209924511256 N209924533144 N2099245666E9 N209924599E1E N2099246029B7 N209924620AA5 N209924646F93 N20992468A5FF N20992469B476 N2099247121E6 N20992472137D N2099247744D0 N20992479ADAE N20992480B3A7 N20992481A22E N209924007D67 N20992487C718 N209924892E66 N20992491BBF6 N20992492896D N2099249398E4 N20992495FDD2 N20992496CF49 N20992508ABF3 N209925103E63 N209925112FEA N20992390267A N209924215F5E N20992509BA7A N209925075304 N20992506428D N212172002D39 N212172013CB0 N21249204E30B N21249205F282 N21249206C019 N21249207D190 N212492082967 N2124920938EE N21197670550D N211976714484 N21197672761F N211976736796 N211976741329 N2119767502A0 N21197676303B N2119767721B2 N21197679C8CC N21197680D6C5 N21197682F5D7 N21197683E45E N2119768490E1 N21197686B3F3 N211976885A8D N211976894B04 N21197690CF1D N21197691DE94 N21197692EC0F N21197693FD86 N211976948939 N2119769598B0 N21197696AA2B N21197697BBA2 N211976984355 N2119769952DC N211977015350 N2119770261CB N211977037042 N2119770404FD N211977051574 N2119770627EF N211977073666 N21197708CE91 N21197709DF18 N211977114A88 N211977127813 N211977141D25 N21249210BCF7 N21249211AD7E N212492129FE5 N212492138E6C N21249214FAD3 N21249215EB5A N21249216D9C1 N2124921830BF N212492192136 N21249220969F N212492218716 N21249222B58D N21249223A404 N21249224D0BB N21249225C132 N21249226F3A9 N21249227E220 N212492281AD7 N212492290B5E N212492308F47 N212492319ECE N21249232AC55 N21249233BDDC N21249234C963 N21249235D8EA N21249236EA71 N21249237FBF8 N21249238030F N21197678D945
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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