Events

Retiro De Equipo (Recall) de Device Recall Siemens MAGNETOM Verio

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 Siemens Medical Solutions USA, Inc.

¿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
    61488
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1364-2012
  • Fecha de inicio del evento
    2012-03-26
  • Fecha de publicación del evento
    2012-04-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108239
  • 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, nuclear magnetic resonance imaging - Product Code LNH
  • Causa
    During product monitoring, siemens has discovered that the gradient cable connections on a few systems did not meet their specifications after installation. the cable connections overheated, leading to the emission of smoke and possible material damage.
  • Acción
    The firm, Siemens Medical Solutions USA, Inc., sent a "Customer Safety Advisory Notice" including Update Instruction MR028/10/S dated March 2012 to affected customers via hand delivery by Siemens Service Engineer . The notice described the product, problem and actions to be taken. The customers were instructed to create a COBR image and to make a copy of the attached "Completion Protocol" fill it out and file in their corresponding binder. Siemens Service Engineer performed an all gradient cable connection visual inspection as well as torque check on the connecting screws at the sites and the factory prior to their release to the field. Siemens also issued a current Update Instruction MR024/11/S. If you have any questions regarding this report, please contact the Quality Engineer, Product Complaints & Field Support at 610-219-4834; email: anastasia.mason@siemens.com or Director, Product Complaints & Field Support at 610-448-4634 or email: josephine.mcbride@siemens.com.

Device

Device Recall Siemens MAGNETOM Verio
  • Modelo / Serial
    Model number 10276755
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution to Washington, DC and the following States: AL, AK, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, and WI. Government Accounts include: BROOKE ARMY MEDICAL CENTER, 3851 ROGER BROOKE DR, FORT SAM HOUSTON, TX 78234; NATIONAL INSTITUTE OF HEALTH, 10 CENTER DRIVE, BETHESDA, MD 20892; NAVAL MEDICAL CENTER, 34800 BOB WILSON DR, SAN DIEGO, CA 92134; US AIR FORCE REGIONAL HOSPITAL, 5955 ZEAMER AVE, ANCHORAGE, AK 99506; VA MEDICAL CENTER, 3350 LA JOLLA VILLAGE DR, SAN DIEGO, CA 92161; VA MEDICAL CENTER, 830 CHALKSTONE AVE, PROVIDENCE, RI 02908; VA MEDICAL CENTER, 109 BEE ST, CHARLESTON, SC 29403; VA MEDICAL CENTER, 10000 BAY PINES BLVD, BAY PINES, FL 33744; VA MEDICAL CENTER, 800 BAILIE DR, AUGUSTA, GA 30901; VA MARTINEZ 612, 150 MUIR RD, MARTINEZ, CA 94553; VA MEDICAL CENTER, 1501 SAN PEDRO SE, ALBUQUERQUE, NM 87108; VA MEDICAL CENTER, 1670 CLAIRMONT RD, DECATUR, GA 30033; VA MEDICAL CENTER - ST LOUIS, 915 N GRAND AVE, ST LOUIS, MO 63106; and VA MEDICAL CENTER HARLINGEN, 2106 TREASURE HILLS BLVD, HARLINGEN, TX 78550. "Other" is National Institute of Health.
  • Descripción del producto
    Siemens MAGNETOM Verio || Use: Nuclear resonance imaging system
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA