Events

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

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, 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
    60126
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1065-2012
  • Fecha de inicio del evento
    2011-10-26
  • Fecha de publicación del evento
    2012-02-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104477
  • 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
    System, x-ray, stationary - Product Code KPR
  • Causa
    Ge healthcare has become aware of a potential issue associated with the hand grip that is clamped to the table top of your revolution xrd x-ray systems that may impact patient safety. the hand grip accessory that is clamped to the table top may not be properly adjusted and can dislodge during use. should this happen during patient loading or unloading, patient injury could occur.
  • Acción
    GE Healthcare sent an Urgent Medical Device Correction letter dated October 24, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to remove the hand grip accessory from use until the product is corrected and to take extra precautions when loading or unloading patients from the table while the hand grips are not in use. A GE Healthcare service representative would contact the consignee to arrange for the correction. For questions regarding this recall call 262-513-4122.

Device

REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
  • Modelo / Serial
    Serial Number 000000PROTOHL3 00000002400HL9 00000013894HL1 00000013895HL8 00000014468HL3 00000014643HL1 00000014646HL4 00000014647HL2 00000014648HL0 00000014649HL8 00000016626HL4 00000016629HL8 00000016630HL6 00000018158HL6 00000018159HL4 00000018160HL2 00000018163HL6 00000018164HL4 00000018649HL4 00000018733HL6 00000018769HL0 00000018804HL5 00000019142HL9 00000019224HL5 00000019387HL0 00000019550HL3 00000019551HL1 00000019712HL9 00000019748HL3 00000019749HL1 00000019750HL9 00000019751HL7 00000019752HL5 00000019754HL1 00000019855HL6 00000019858HL0 00000019861HL4 00000019925HL7 00000020047HL7 00000020048HL5 00000020049HL3 00000020050HL1 00000020051HL9 00000020053HL5 00000020275HL4 00000020276HL2 00000020277HL0 00000020279HL6 00000020280HL4 00000020281HL2 00000020283HL8 00000020287HL9 00000020289HL5 00000020290HL3 00000020295HL2 00000020297HL8 00000020298HL6 00000020299HL4 00000020300HL0 00000020301HL8 00000020302HL6 00000020304HL2 00000020305HL9 00000020306HL7 00000020307HL5 00000020309HL1 00000020311HL7 00000021375HL1 00000021376HL9 00000021377HL7 00000021916HL2 00000022300HL8 00000022356HL0 00000022359HL4 00000022361HL0 00000022364HL4 00000022365HL1 00000022494HL9 00000022495HL6 00000022499HL8 00000023345HL2 00000023346HL0 00000023356HL9 00000023568HL9 00000023582HLO 00000023582HL0 00000023640HL6 00000023642HL2 00000023643HL0 00000023644HL8 00000023645HL5 00000023706HL5 00000023707HL3 00000023708HL1 00000023932HL7 00000023934HL3 00000023935HL0 00000024598HL5 00000024600HL9 00000024601HL7 00000024602HL5 00000024605HL8 00000024686HL8 00000024695HL9 00000024696HL7 00000024930HL0 00000024932HL6 00000024933HL4 00000024934HL2 00000024935HL9 00000024936HL7 00000025333HL6 00000025395HL5 00000025396HL3 00000025463HL1 00000025464HL9 00000025465HL6 00000025599HL2 00000025601HL6 00000025602HL4 00000025603HL2 00000025604HL0 00000026100HL8 00000026101HL6 00000026102HL4 00000027827HL5 00000027828HL3 00000027830HL9 00000027831HL7 00000027832HL5 00000028087HL5 00000028088HL3 00000028268HL1 00000028392HL9 00000028393HL7 00000028723HL5 00000028764HL9 00000028765HL6 00000028767HL2 00000028893HL6 00000028894HL4 00000028895HL1 00000028896HL9 00000028897HL7 00000029009HL8 00000029011HL4 00000029042HL9 00000029043HL7 00000029200HL3 00000029300HL1 00000029541HL0 00000029542HL8 00000029598HL0 00000029715HL0 00000029716HL8 00000029717HL6 00000029788HL7 00000029789HL5 00000029791HL1 00000029832HL3 00000029833HL1 00000029855HL4 00000029856HL2 00000029894HL3 00000029895HL0 00000029896HL8 00000029897HL6 00000029898HL4 00000029983HL4 00000029984HL2 00000030099HL6 00000030100HL2 00000030154HL9 00000030155HL6 00000030300HL8 00000030478HL2 00000030521HL9 00000030522HL7 00000030524HL3 00000030527HL9 00000030657HL1 00000030872HL6 00000030934HL4 00000031030HL0 00000031058HL1 00000031059HL9 00000031196HL9 00000031197HL7 00000031244HL7 00000031413HL8 00000031474HL0 00000031518HL4 00000031520HL0 00000031521HL8 00000031522HL6 00000031643HL0 00000031647HL1 00000031723HL0 00000031726HL3 00000031827HL9 00000031829HL5 00000031830HL3 00000031831HL1 00000031832HL9 00000031833HL7 00000032058HL0 00000032059HL8 00000032060HL6 00000032119HL0 00000032121HL6 00000032196HL8 00000032197HL6 00000032198HL4 00000032199HL2 00000032245HL3 00000032246HL1 00000032247HL9 00000032344HL4 00000032345HL1 00000032416HL0 00000032417HL8 00000032444HL2 00000032448HL3 00000032449HL1 00000032476HL4 00000032478HL0 00000032539HL9 00000032540HL7 00000032542HL3 00000032612HL4 00000032613HL2 00000032684HL3 00000032685HL0 00000032767HL6 00000032768HL4 00000032975HL5 00000033053HL0 00000033054HL8 00000033055HL5 00000033110HL8 00000033113HL2 00000033334HL4 00000033335HL1 00000033337HL7 00000033338HL5 00000033404HL5 00000033405HL2 00000033406HL0 00000033487HL0 00000033517HL4 00000033518HL2 00000033519HL0 00000033520HL8 00000033521HL6 00000033592HL7 00000033593HL5 00000033594HL3 00000033595HL0 00000033687HL5 00000033688HL3 00000033689HL1 00000033690HL9 00000033692HL5 00000033770HL9 00000033814HL5 00000033842HL6 00000033843HL4 00000033844HL2 00000033890HL5 00000033891HL3 00000033892HL1 00000034011HL7 00000034014HL1 00000034056HL2 00000034057HLO 00000034162HL8 00000034180HL0 00000034181HL8 00000034182HL6 00000034265HL9 00000034329HL3 00000034331HL9 00000034391HL3 00000034392HL1 00000034406HL9 00000034409HL3 00000034529HL8 00000034530HL6 00000034531HL4 00000034532HL2 00000034533HL0 00000034587HL6 00000034590HL0 00000034742HL7 00000034743HL5 00000034791HL4 00000034793HL0 00000034830HL0 00000034831HL8 00000034878HL9 00000034879HL7 00000034880HL5 00000034881HL3 00000034915HL9 00000034916HL7 00000034976HL1 00000034977HL9 00000034978HL7 00000034979HL5 00000034980HL3 00000034981HL1 00000034982HL9 00000034984HL5 00000035029HL6 00000035064HL5 00000035065HL2 00000035066HL0 00000035085HL0 00000035086HL8 00000035087HL6 00000035209HL6 00000035232HL5 00000035323HL5 00000035324HL3 00000035326HL8 00000035524HL8 00000035592HL5 00000035593HL3 00000035594HL1 00000035595HL8 00000035596HL6 00000035597HL4 00000035635HL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  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WY, WI and the countries of VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TAIWAN, SWITZERLAND, SPAIN, SLOVENIA, SAUDI ARABIA, REPUBLIC OF KOREA, NORWAY, NEW ZEALAND, NETHERLANDS, MALTA, KUWAIT, JORDAN, JAPAN, ITALY, ISRAEL, HONG KONG, GERMANY, FRANCE, ECUADOR, DENMARK, CZECH REPUBLIC, CHINA, CHILE, CANADA, and AUSTRALIA.
  • Descripción del producto
    REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS || The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for mammographic use.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

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