Events

Retiro De Equipo (Recall) de Device Recall Proteus

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por GE Healthcare.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    46859
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0842-2008
  • Fecha de inicio del evento
    2007-11-01
  • Fecha de publicación del evento
    2008-06-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68347
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    x-ray system - Product Code KPR
  • Causa
    The warning label that is required by 21 cfr 1020.30(j) was not on the control console of the proteus xr/a radiographic x-ray system, model 2259976.
  • Acción
    GE issued a Field Modification Instruction to their field service representatives, released in December 2007, with instructions to replace the labels on the console with the appropriate labeling. Consignees will be visited by GE field service representatives beginning December 2007. All consignees will have the required labels affixed to their units by July 31, 2008.

Device

Device Recall Proteus
  • Modelo / Serial
    00000010838HL1, 00000011061HL9, 00000011067HL6, 00000011185HL6, 00000012500HL5, 00000012667HL2, 00000013129HL2, 00000013372HL8, 00000013385HL0, 00000013543HL4, 00000013557HL4, 00000013800HL8, 00000014099HL6, 00000014104HL4, 00000014319HL8, 00000014327HL1, 00000014667HL0, 00000014677HL9, 00000015076HL3, 00000015383HL3, 00000015386HL6, 00000015400HL5, 00000015738HL8, 00000015744HL6, 00000015745HL3, 00000015750HL3, 00000015760HL2, 00000016174HL5, 00000016383HL2, 00000016386HL5, 00000016696HL7, 00000016707HL2, 00000016708HL0, 00000016709HL8, 00000016930HL0, 00000016954HL0, 00000016955HL7, 00000017119HL9, 00000017130HL6, 00000017131HL4, 00000017476HL3, 00000017477HL1, 00000017478HL9, 00000017480HL5, 00000017490HL4, 00000017492HL0, 00000017493HL8, 00000017599HL2, 00000017604HL0, 00000017608HL1, 00000017610HL7, 00000017613HL1, 00000017616HL4, 00000017788HL1, 00000017801HL2, 00000018476HL2, 00000018479HL6, 00000018483HL8, 00000019041HL3, 00000019048HL8, 00000019095HL9, 00000019098HL3, 00000019104HL9, 00000019110HL6, 00000019241HL9, 00000019244HL3, 00000019413HL4, 00000019419HL1, 00000019489HL4, 00000019496HL9, 00000019499HL3, 00000019501HL6, 00000019502HL4, 00000019669HL1, 00000019801HL0, 00000019886HL1, 00000019894HL5, 00000019959HL6, 00000020091HL5, 00000020092HL3, 00000020239HL0, 00000020243HL2, 00000020374HL5, 00000020967HL6, 00000021064HL1, 00000021197HL9, 00000021201HL9, 00000021204HL3, 00000021343HL9, 00000021344HL7, 00000021349HL6, 00000021552HL5, 00000021911HL3, 00000021921HL2, 00000021938HL6, 00000021953HL5, 00000022033HL5, 00000022333HL9, 00000022337HL0, 00000022412HL1, 00000022477HL4, 00000022600HL1, 00000022795HL9, 00000022931HL0, 00000023116HL7, 00000023122HL5, 00000023126HL6, 00000023412HL0, 00000023415HL3, 00000024386HL5, 00000024483HL0, 00000024588HL6, 00000024939HL1, 00000024940HL9, 00000025426HL8, 00000025475HL5, 00000025476HL3, 00000025477HL1, 00000025572HL9, 00000027104HL9, 00000027867HL1, 00000028057HL8, 00000028453HL9, 00000028524HL7, 00000028845HL6, 00000029098HL1, 00000029145HL0, 00000029502HL2, 00000029550HL1, 00000029634HL3, 00000029640HL0, 00000029969HL3, 00000030108HL5, 00000030113HL5, 00000030229HL9, 00000030232HL3, 00000030236HL4, 00000030633HL2, 00000030848HL6, 00000030920HL3, 00000030921HL1, 00000030976HL5, 00000031172HL0, 00000031175HL3, 00000031565HL5, 00000031702HL4, 00000031811HL3, 00000031928HL5, 00000031929HL3, 00000031930HL1, 00000032309HL7, 00000032311HL3, 00000032317HL0, 00000032319HL6, 00000032322HL0, 00000032850HL0, 00000032912HL8, 00000032916HL9, 00000032919HL3, 00000032920HL1, 00000033330HL2, 00000033388HL0, 00000033391HL4, 00000033408HL6, 00000033437HL5, 00000033509HL1, 00000033679HL2, 00000033681HL8, 00000033682HL6, 00000033727HL9, 00000033731HL1, 00000033884HL8, 00000033970HL5, 00000033971HL3, 00000033983HL8, 00000033984HL6, 00000034218HL8, 00000034420HL0, 00000034469HL7, 00000034470HL5, 00000034520HL7, 00000034644HL5, 00000034694HL0, 00000034762HL5, 00000034764HL1, 00000034913HL4, 00000034938HL1, 00000035052HL0, 00000035101HL5, 00000035159HL3, 00000035191HL6, 00000035244HL3, 00000035246HL8, 00000035247HL6, 00000035329HL2, 00000035445HL6, 00000035544HL6, 00000035547HL9, 00000035632HL9, 00000035641HL0, 00000036038HL8, 00000036068HL5, 00000036071HL9, 00000036100HL6, 00000036126HL1, 00000036128HL7, 00000036265HL7, 00000036362HL2, 00000036363HL0, 00000036431HL5, 00000036624HL5, 00000036625HL2, 00000036674HL0, 00000036698HL9, 00000036702HL9, 00000036882HL9, 00000036983HL5, 00000037104HL7, 00000037123HL7, 00000037351HL4, 00000037352HL2, 00000037353HL0, 00000037396HL9, 00000037596HL4, 00000037919HL8, 00000038423HL0, 00000038771HL2, 00000038772HL0, 00000039125HL0, 00000039581HL4, 00000039612HL7, 00000040366HL7, 00000040493HL9, 00000040728HL8, 00000040865HL8, 00000041290HL8, 00000041291HL6, 00000041511HL7, 00000041768HL3, 00000042367HL3, 00000042649HL4, 00000042650HL2, 00000042651HL0, 00000042701HL3, 00000042880HL5, 00000043029HL8, 00000043184HL1, 00000043265HL8, 00000043665HL9, 00000043727HL7.00000043747HL5, 00000043751HL7, 00000044548HL6, 00000045475HL1, 00000045651HL7, 00000015925HL1, 00000019969HL5, 00000024476HL4, 00000027957HL0, 00000030025HL1, 00000030028HL5, 00000032711HL4, 00000035548HL7, 00000036428HL1, 00000036883HL7, 00000020371HL1, 00000021582HL2, 00000031922HL8, 00000033316HL1, 00000042706HL2, 00000020735HL7, 00000022513HL6, 00000022926HL0, 00000024376HL6, 00000031909HL5, 00000040521HL7, 00000041017HL5, 00000011544HL4, 00000014336HL2, 00000016171HL1, 00000016545HL6, 00000017123HL1, 00000017483HL9, 00000023189HL4, 00000028833HL2, 00000030875HL9, 00000030924HL5, 00000031916HL0, 00000031918HL6, 00000032909HL4, 00000033730HL3, 00000033974HL7, 00000034268HL3, 00000036165HL9, 00000042001HL8, 00000016177HL8, 00000031554HL9, 00000036626HL0, 00000013383HL5, 00000014323HL0, 00000019485HL2, 00000020232HL5, 00000010836HL5, 00000019679HL0, 00000023546HL5, 00000023547HL3, 00000030926HL0, 00000041996HL0, 00000042388HL9, 00000042537HL1, 00000011063HL5, 00000015391HL6, 00000017138HL9, 00000021058HL3, 00000030918HL7, 00000040086HL1, 00000010328HL3, 00000013375HL1, 00000014335HL4, 00000015065HL6, 00000015081HL3, 00000015747HL9, 00000016371HL7, 00000016701HL5, 00000017125HL6, 00000017481HL3, 00000019482HL9, 00000019486HL0, 00000019678HL2, 00000019680HL8, 00000019788HL9, 00000020081HL6, 00000020224HL2, 00000021639HL0, 00000022032HL7, 00000023118HL3, 00000023181HL1, 00000024432HL7, 00000029259HL9, 00000031908HL7, 00000031914HL5, 00000032231HL3, 00000032897HL1, 00000033724HL6, 00000033725HL3, 00000033968HL9, 00000034260HL0, 00000034459HL8, 00000034462HL2, 00000034783HL1, 00000035377HL1, 00000035378HL9, 00000036563HL5, 00000037254HL0, 00000038190HL5, 00000016175HL2, 00000019042HL1, 00000013796HL8, 00000011182HL3, 00000032313HL9, 00000012475HL0, 00000020222HL6, 00000029743HL2, 00000033726HL1, 00000020732HL4, 00000020737HL3, 00000012674HL8, 00000021551HL7, 00000031689HL3, 00000010651HL8, 00000015757HL8, 00000022520HL1, 00000015082HL1, 00000015153HL0, 00000021644HL0, 00000013373HL6, 00000015158HL9, 00000022606HL8, 00000022607HL6, 00000024489HL2, 00000024590HL2, 00000024671HL0, 00000024689HL2, 00000030446HL9, 00000030460HL0, 00000030927HL8, 00000036429HL9, 00000015387HL4, 00000039893HL3, 00000039895HL8, 00000039962HL6, 00000040002HL8, 00000040072HL1, 00000040164HL6, 00000040167HL9, 00000022402HL2, 00000036266HL5, 00000036914HL0, 00000037252HL4, 00000013564HL0.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution, including USA, Canada, Mexico, France, Hong Kong, Italy, Korea, China, Poland, UK, New Zealand, Saudi Arabia, Taiwan, Turkey, and Australia.
  • Descripción del producto
    GE Healthcare Proteus XR/a Radiographic X-ray System, Model Number 2259976; previously marketed as the Silhouette FC, GE Healthcare, Waukesha, WI 53188.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Dirección del fabricante
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA