Events

Rappel de Device Recall Proteus

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par GE Healthcare.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    46859
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0842-2008
  • Date de mise en oeuvre de l'événement
    2007-11-01
  • Date de publication de l'événement
    2008-06-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68347
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    x-ray system - Product Code KPR
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution, including USA, Canada, Mexico, France, Hong Kong, Italy, Korea, China, Poland, UK, New Zealand, Saudi Arabia, Taiwan, Turkey, and Australia.
  • Description du dispositif
    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
  • Adresse du fabricant
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA