Events

Recall of Device Recall Proteus

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    46859
  • Event Risk Class
    Class 2
  • Event Number
    Z-0842-2008
  • Event Initiated Date
    2007-11-01
  • Event Date Posted
    2008-06-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68347
  • Notes / Alerts
    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.
  • Extra notes in the data
    x-ray system - Product Code KPR
  • Reason
    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
  • Model / 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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution, including USA, Canada, Mexico, France, Hong Kong, Italy, Korea, China, Poland, UK, New Zealand, Saudi Arabia, Taiwan, Turkey, and Australia.
  • Product Description
    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
  • Manufacturer Address
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA