Devices

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
  • 1 Event

Fabricant

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

14 dispositifs médicaux avec un nom similaire

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Device Recall ProteusPLUS
  • Modèle / numéro de série
    Serial numbers: PAT.000, PAT.001, PAT.003, PAT.006, PAT.108, PAT.111, SAT.119, SAT.120
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in MA, FL, VA, and TN. China, South Korea, France and Germany
  • Description du dispositif
    Proteus 235
  • Manufacturer
    Ion Beam Applications S.A.
Device Recall Proteus Plus
  • Modèle / numéro de série
    Serial Number: SAT.123 (US), and SBF.101 (EU). Versions PTS-9.3.1.2 and PTS-9.4.0
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution in US (to Louisiana), and France.
  • Description du dispositif
    Proteus 235, Proton Therapy System
  • Manufacturer
    Ion Beam Applications S.A.
Device Recall Proteus Plus and Proteus ONE
  • Modèle / numéro de série
    Serial Numbers: PAT.000,PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.111, PAT.112, PAT.113, PAT.114, SAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : MA, FL, VA, PA, IL, NJ, WA, TN, LA and TX., and to the countries of: Germany, South Korea, France, Czech Republic, Italy, Poland and Sweden.
  • Description du dispositif
    Proteus 235
  • Manufacturer
    Ion Beam Applications S.A.
Device Recall Proteus 235 and Proteus ONE proton therapy systems
  • Modèle / numéro de série
    Code/Serial Numbers: PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.112, PAT.113, PAT.114, PAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123 and SAT.126
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Products distributed to FL, VA, PA, OK, IL, NJ, WA, TN, LA, TX, South Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden
  • Description du dispositif
    Proteus 235 and Proteus ONE proton therapy systems
  • Manufacturer
    Ion Beam Applications S.A.
Device Recall ProteusPlus
  • Modèle / numéro de série
    Serial Numbers: PAT.006, PAT.108, PAT.112, PAT.113, SAT.116, PAT.003
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed to FL, VA, IL, NJ, WA and South Korea
  • Description du dispositif
    Proteus 235, Proton Therapy System || Product Usage: || The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
  • Manufacturer
    Ion Beam Applications S.A.
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