Events

Retiro De Equipo (Recall) de REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM

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 Medical Systems, LLC.

¿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
    52010
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0527-2010
  • Fecha de inicio del evento
    2009-08-13
  • Fecha de publicación del evento
    2009-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81887
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code KPR
  • Causa
    Certain ge radiographic fixed x-ray tables (proteus xr/a, revolution xr/d, and definium 8000) were found to have tabletops that move unexpectedly in a bi-directional mode. in rare cases, a malfunction may occur, which could result in the tabletop brakes falling to engage when the control foot pedal is released to lock the floating tabletop in place.
  • Acción
    A GE Healthcare "Urgent Medical Device Correction" letter dated April 9, 2009 was issued to customers. The letter was addressed to Hospital Administrators/Managers of Radiology and Radiologists. The letter described the Product Issue, Affected Product, Safety Instructions, Product Correction and Contact Information. Operators should verify that the tabletop is locked before the patient is loaded on or off the table. A Field Modification will be performed on the affected products. A GE Healthcare Field Engineer will schedule a field visit to make this modification. Direct questions or concerns regarding the recall to your local GE Healthcare service representative or by calling 1-262-853-7685.

Device

REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM
  • Modelo / Serial
    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034979HL5 00000033113HL2 00000032542HL3 00000030527HL9 00000031832HL9 00000035066HL0 00000034531HL4 00000034978HL7 00000034881HL3 00000025395HL5 00000038776HL1 00000039283HL7 00000013894HL1 00000034533HL0 00000036195HL6 00000019924HL0 00000023640HL6 00000036051HL1 00000025333HL6 00000036896HL9 00000029716HL8 00000030934HL4 00000028393HL7 00000029541HL0 00000019752HL5 00000019925HL7 00000025599HL2 00000028087HL5 00000020295HL2 00000029300HL1 00000036142HL8 00000040676HL9 00000036893HL6 00000033891HL3 00000037724HL2 00000022364HL4 00000040018HL4 00000033338HL5 00000022365HL1 00000036300HL2 00000032199HL2 00000032247HL9 00000032121HL6 00000029895HL0 00000037132HL8 00000029789HL5 00000040017HL6 00000037603HL8 00000029832HL3 00000029896HL8 00000028897HL7 00000029717HL6 00000018158HL6 00000033337HL7 00000034409HL3 00000035524HL8 00000032060HL6 00000032059HL8 00000031647HL1 00000033487HL0 00000040019HL2 00000033890HL5 00000034793HL0 00000033690HL9 00000033814HL5 00000024934HL2 00000038024HL6 00000041433HL4 00000040278HL4 00000029898HL4 00000040277HL6 00000020306HL7 00000034162HL8 00000023356HL9 00000036417HL4 00000024695HL9 00000014649HL8 00000041439HL1 00000036001HL6 00000031520HL0 00000037384HL5 00000028893HL6 00000034406HL9 00000035085HL0 00000040125HL7 00000040868HL2 00000033404HL5 00000028088HL3 00000037897HL6 00000029856HL2 00000029855HL4 00000033892HL1 00000037275HL5 00000029715HL0 00000018649HL4 00000018733HL6 00000033745HL1 00000032416HL0 00000033593HL5 00000033517HL4 00000023934HL3 00000033592HL7 00000033692HL5 00000033594HL3 00000033521HL6 00000035324HL3 00000034981HL1 00000031724HL8 00000033518HL2 00000030527HL6 00000030933HL6 00000031196HL9 00000031057HL3 00000031058HL1 00000031247HL0 00000031244HL7 00000031409HL6 00000031412HL0 00000031522HL6 00000031518HL4 00000031523HL4 00000031646HL3 00000031726HL3 00000036596HL5 00000037547HL7 00000037727HL5 00000037725HL9 00000036145HL1 00000038091HL5 00000038021HL2 00000038774HL6 00000038022HL0 00000034163HL6 00000041123HL1 00000041273HL4 00000041352HL6 00000040420HL2 00000041434HL2 00000035170HL0 00000034831HL8 00000016625HL6 00000018156HL0 00000017074HL6 00000020296HL0 00000020286HL1 00000023358HL5 00000029714HL3 00000033815HL2 00000033812HL9 00000037726HL7 00000033812HL9 00000034741HL9 00000037136HL9 00000002666EN6 00000025600HL8 00000017073HL8 00000017075HL3 00000018154HL5 00000018162HL8 00000022363HL6 00000023931HL9 00000029599HL8 00000028766HL4 00000023583HL8 00000032770HL0 00000038088HL1 00000040801HL3 00000022497HL2 00000034410HL1 00000035171HL8 00000036814HL2 00000036196HL4 00000039085HL6 00000039086HL4 00000038773HL8 00000034914HL2 00000016628HL0 00000014650HL6 00000019859HL8 00000020308HL3  00000022362HL8 00000019856HL4 00000034740HL1 00000034393HL9 00000034407HL7 00000030299HL2 00000032541HL5 00000036197HL2 00000026099HL2 00000028898HL5 00000031246HL2 00000031201HL7 00000033402HL9 00000033112HL4 00000034688HL2 00000037899HL2 00000037606HL1 00000038486HL7 00000038363HL8 00000040175HL2 00000034832HL6 00000036047HL9 00000018647HL8 00000019854HL9 00000019141HL1 00000018650HL2 00000019711HL1 00000017068HL8 00000020046HL9 00000019926HL5 00000017072HL0 00000019755HL8 00000023569HL7 00000019927HL3 00000029857HL0 00000028722HL7 00000031121HL7 00000030525HL0 00000019927HL3 00000037605HL3 00000001914HL1 00000029301HL9 00000037548HL5 00000020274HL7 00000023359HL3 00000015863HL4 00000036370HL5 00000034183HL4 00000029303HL5 00000037604HL6 00000019143HL7 00000035169HL2 00000036048HL7 00000030658HL9 00000035325HL0 00000033811HL1 00000961628WK5 00000040924HL3 00000040925HL0 00000018803HL7 00000019222HL9 00000037272HL2 00000021917HL0 00000021919HL6 00000022360HL2     00000023581HL2 00000014645HL6 00000035923HL2 00000029012HL2 00000033927HL5 00000037273HL0 00000031642HL2 00000031642HL2 00000031642HL2 00000020284HL6 00000035167HL6 00000018155HL2 00000032683HL5 00000018155HL2 00000036144HL4 00000031828HL7 00000016627HL2 00000029003HL1 00000029540HL2 00000031199HL7 00000035523HL0 00000020288HL7 00000020293HL7 00000020285HL3 00000029302HL7 00000038484HL2 00000031721HL4 00000030873HL4 00000035327HL6 00000030480HL8 00000030479HL0 00000022302HL4 00000030659HL7 00000019857HL2 00000019713HL7 00000026100HL8 00000021378HL5 00000029171HL6 00000034009HL1 00000032976HL3 000000032976HL 00000033336HL9 00000034013HL3 00000033109HL0 00000033403HL7 00000034983HL7 00000034010HL9 00000035322HL7 00000030932HL8 00000031122HL5 00000031245HL4 00000031200HL9 00000031475HL7 00000032477HL2 00000034012HL5 00000024688HL4 00000032118HL2 00000018161HL0 00000025334HL4 00000032244HL6 00000033407HL8 00000031722HL2 00000029004HL9 00000036276HL4 00000035068HL6 00000018157HL8 00000030153HL1 00000031411HL2 00000023930HL1 00000032120HL8 00000022301HL6 00000030526HL8 00000033691HL7 00000033813HL7 00000034690HL8 00000036508HL0 00000036897HL7 00000038286HL1 00000037043HL7 00000038284HL6 00000041350HL0 00000035208HL8 00000020294HL5 00000031648HL9 00000037381HL1 00000023709HL9 00000027829HL1 00000031198HL5 00000032445HL9 00000041438HL3 00000020291HL1 00000022496HL4 00000031644HL8 00000031519HL2 00000034687HL4 00000034689HL0 00000039778HL6 00000039971HL7 00000038285HL3 00000039972HL5 00000031725HL5 00000030528HL4 00000030156HL4 00000031645HL5 00000032445HL9 00000030660HL5 00000034792HL2 00000029168HL2 00000029169HL0 00000019386HL2 00000017070HL4 00000018648HL6 00000023582HL0 00000023641HL4 00000023704HL0 00000023705HL7 00000023933HL5 00000024603HL3 00000024604HL1 00000024687HL6 00000024793HL2 00000024931HL8 00000025463HL1 00000025466HL4 00000028267HL3 00000029010HL6 00000029201HL1 00000030154HL9 00000031827HL9 00000032769HL2 00000033111HL6 00000033889HL7 00000034266HL7 00000034330HL1 00000034408HL5 00000034588HL4 00000034589HL2 00000034830HL0 00000035067HL8 00000035168HL4 00000035210HL4 00000035847HL3 00000035926HL5 00000036143HL6 and 00000037383HL7.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- UNITED STATES (including Puerto Rico), VIETNAM, VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TURKS AND CAICOS ISLANDS, TURKEY, TUNISIA, TRINIDAD AND TOBAGO, THAILAND, TAIWAN, SWITZERLAND, SWEDEN SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIA, PORTUGAL POLAND, PANAMA, PAKISTAN, NORWAY NEW ZEALAND, NETHERLANDS , MEXICO MARTINIQUE, MALTA, MALAYSIA, LITHUANIA, LABA NON, LATVIA, KUWAIT, REPUBLIC OF KOREA, KAZAKSTAN, JORDAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, INDONESIA, INDIA, ICELAND, HUNGARY, HONG KONG, GUAM, GREECE, GERMANY, FRENCH POLYNESIA, FRANCE FINLAND , ECUADOR, DENMARK CZECH REPUBLIC, CROATIA, COLUMBIAN, CHINA, CHILE , CANDA, BULGARIA, BRAZIL, BOSNIA, BELGIUM AUSTRIA, AUSTRALIA, and ARGENTINA.
  • Descripción del producto
    GE Healthcare Revolution XR/d. Model #'s 2259988-2 & 2351505. || GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. || The Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. It is intended to replace radiographic films/screen systems in all general purpose diagnostic procedures. The device is not intended for mammographic applications.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

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