Events

Retiro De Equipo (Recall) de Device Recall GE Healthcare, Seno Advantage 2.1 and 2.2 Workstations

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
    59059
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3012-2011
  • Fecha de inicio del evento
    2011-05-31
  • Fecha de publicación del evento
    2011-08-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100969
  • 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, image processing, radiological - Product Code LLZ
  • Causa
    Ge healthcare has become aware that patient mismatch could occur on some seno advantage 2.1 and 2.2 workstations with ris ccow integration. this issue may impact patient safety. when seno advantage workstation is synchronized with ris using ccow (an hl7 standard protocol designed to enable disparate applications to synchronize in real-time), the following issues could occur: 1. two different.
  • Acción
    GE Healthcare sent a URGENT MEDICAL DEVICE CORRECTION letter to all affected customers dated May 31, 2011. The letter identified the product , the problem and the action needed to be taken by the customer. GE Healthcare will upgrade all affected workstations at no cost. A GE Healthcare service representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please call one of the following phone numbers: United States: 800 437 1171 Japan: 0120 - 055 - 919 For other countries, please contact your local GE Healthcare Service Representative

Device

Device Recall GE Healthcare, Seno Advantage 2.1 and 2.2 Workstations
  • Modelo / Serial
    00000112926GE1 00000114903GE8 00000099996GE1 00000090034GE0 00000106421GE1 00000099995GE3 00000099999GE5 00000142841GE6 00000075247GE7 00000090027GE4 00000090035GE7 00000112124GE3 00000090028GE2 00000128524GE6 00000123805GE4 00000084251GE8 00000090032GE4 00000090030GE8 00000114902GE0 00000114904GE6 00000114907GE9 00000103152GE5 00000142833GE3 00000117138GE8 00000126080GE1 00000106426GE0 00000114091GE2 00000128525GE3 00000106422GE9 00000106423GE7 00000112122GE7 00000112123GE5 00000123807GE0 00000117141GE2 00000123803GE9 00000123804GE7 00000142832GE5 00000136611GE1 00000128528GE7 00000126081GE9 00000132306GE2 00000126082GE7 00000132314GE6 00000142835GE8 00000142837GE4 00000142839GE0 00000142836GE6 00000147369GE3 00000149799GE9 00000154940GE1 00000158811GE0 00000158814GE4 00000164500GE1 00000165231GE2 00000166279GE0 00000180129GE9 00000180127GE3 00000166280GE8 00000174024GE0 00000166281GE6 00000177327GE4 00000174026GE5 00000174027GE3 00000166282GE4 00000195402GE3 00000195403GE1 00000080399GE3 00000177331GE6 00000179272GE0 00000179273GE8 00000179274GE6 00000179281GE1 00000179282GE9 00000188371GE9 00000193278GE9 00000114088GE8 00000114089GE6 00000195401GE5 00000206492GE1 00000206491GE3 00000200440GE6 00000190780GE7 00000106427GE8 00000200442GE2 00000128529GE5 00000090033GE2 00000170113GE2 00000218674GE0 00000218675GE7 00000220618GE3 00000158410GE1 00000158809GE4 00000103151GE7 00000080399GE9 00000090026GE6 00000132309GE6 00000106424GE5 00000106425GE2 00000114905GE3 00000154938GE5 00000126078GE5 00000126079GE3 00000119930GE6 00000119931GE4 00000114906GE1 00000132310GE4 00000136608GE7 00000136609GE5 00000136610GE3 00000142838GE2 00000152337GE2 00000174023GE2 00000158810GE2 00000166277GE4 00000164502GE7 00000164503GE5 00000164504GE3 00000158812GE8 00000158813GE6 00000165228GE8 00000165229GE6 00000166278GE2 00000180131GE5 00000180132GE3 00000193275GE5 00000193276GE3 00000179278GE7 00000200441GE4 00000206489GE7 00000179275GE3 00000179279GE5 00000180128GE1 00000179280GE3 00000195404GE9 00000195405GE6 00000206490GE5 00000212965GE8 00000212966GE6 00000212967GE4 00000114092GE0 00000114093GE8 00000114094GE6 00000114095GE3 00000164501GE9 00000149802GE1 00000149801GE3 00000165230GE4 00000180130GE7 00000117140GE4 00000117137GE0 00000165227GE0 00000114090GE4 00000117136GE2 00000114908GE7 00000126077GE7 00000132307GE0 00000132308GE8 00000132315GE3 00000136604GE6 00000142834GE1 00000152336GE4 00000193277GE1 00000119932GE2 00000119933GE0 00000149803GE9 00000218673GE2 000000Y8350001 000000F9097001 000000R9058001 00000H10238001 00000T10230001 000000R8221001 000000C8140001 00000V11063002 000000J8147001 000000S8135001 00000ZA9233001 00000J10019001 000000G9278001 00000D10166001 000000S8340001 000000Q8352001 000000T8353001 000000Y8350002 00000N10193003 00000G10337001 000000ANT23042 000000ANT23043 000000ANT25610 000000ANT25612 000000U7164002 0000AB11012001 0000AB11012002 00000M11006003 000000T7323001 000000S9232001 00000V10329001 00000G10264001 00000D10333001 00000J10209001 00000K10351001 00000T10319001 00000050604AW8 00000050605AW5 000000Q7274001 000000U7164006 00000050607AW1 00000054750AW5 00000054849AW5 000000T7323003 000000G8021002 000000T7323002 000000S8135002 000000C7177017 000000C7177020 000000P8081001 000000W9301001 000000B7352001 000000T9021003 000000C7177003 000000K8210001 00000G10264002 000000G8225001 000000ANT23048 000000K8046001 000000ANT25614 000000P8207001 000000ANT22005 000000S8135003 000000J8147003 000000AA804301 000000ZA801701 00000M10015001 00000D10301002 00000F10243001 000000C7177016 000000J8147002 000000J8147005 000000P8207002 000000P8207003 000000S8135004 000000R9029001 000000N7302006 000000F8156001 000000D8213002 000000C8227001 000000V8338002 000000D9222001 000000M9335002 00000H10110001 00000N10193001 00000L10047001 00000C10077002 00000Y10214002 00000C10077001 00000B10265003 00000B10265004 00000R10123001 00000R10123002 00000D10202001 00000M10223001 00000J10308001 00000M11006001 000000C8140002 000000A8207001 000000A8207002 000000F8206001 00000050608AW9 000000ANT25615 000000Q7274002 000000F7282001 000000F7282002 000000N7302004 000000N7302005 000000B7352002 000000AG805202 000000AG805203 000000T8296001 000000ZA828801 000000F7288001 000000K7291001 000000P8233001 000000P8233002 000000AG805205 000000AG805206 000000AG805207 000000D8213001 000000AG805201 000000F8156002 000000D8247002 000000U9022001 000000T9021001 000000M9240001 000000T9218001 000000P9138001 000000S9118001 00000M10015002 000000R9345001 000000N9216001 000000T9146001 00000Y10012001 00000Y10012002 00000Y10012003 000000M9335001 000000Q9257001 000000X9309001 00000B10217001 00000B10217002 00000P10210001 00000Y10214001 00000L10151002 00000M10223004 00000S10320001 00000D10301001 000000Q7274004 000000U9049001 000000S9055001 000000C7177019 000000AG805204 000000R9131001 000000V8338001 000000W9043001 000000T9146002 000000L9091001 000000T9146003 00000N10071001 00000P10046001 00000K10076001 00000M11006002 00000K10076002 000000X9309002 000000C7177004 000000ANT23049 000000U7164001 000000U7164003 000000U7164004 000000T7323004 000000C7177015 000000C7177008 000000C7177009 000000C7177010 000000Q7274005 000000K7291002 000000U9077001 000000R9131003 000000R9131004 00000Q11031001 00000Q11031003 000000ANT23045 000000ANT23046 000000ANT23047 000000ANT25611 000000N7302001 00000F10243002 00000F10243003 00000L10092001 00000M10223002 00000M10223003 000000G9278003 000000G9278004 000000G9278005 000000N7302002 000000S8206001 000000P9314001 000000U7164005 000000C7177002 000000G8021001 000000W8297001 000000ANT26269 000000G8087001 000000G8087002 000000ANT25613 000000ANT23044 000000C7177007 00000106420GE3 00000142840GE8 00000168707GE8 00000170713GE2 00000220619GE1 00000218672GE4 00000220620GE9 00000L10151001 00000K10032001 000000D8247001 000000T9021002 000000U9077002 000000R9131002 00000Y10214003 00000050606AW3 000000N7302003 000000W9301002
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) including the states of: AZ, CA, CO, CT, FL, GA, HI, IL, IN, IA, LA, MD, MA, MI, MN, MO, MT, NE, NJ, NY, NC, OK, OR, PA, SC, TN,TX, and WI, and the countries of UNITED KINGDOM, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, PORTUGAL NORWAY, NEW ZEALAND, LUXEMBOURG, LEBANON, KOREA, JAPAN, ITALY, IRELAND, GERMANY, FRANCE, DENMARK, CANADA, BELGIUM AUSTRIA, AUSTRALIA FINLAND.
  • Descripción del producto
    GE Healthcare, Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration, GE Healthcare 3000 North Grandview, Waukesha, WI 53188 || Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.
  • 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