Events

Retiro De Equipo (Recall) de Device Recall e.cam Dual Signature; Gamma Camera

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
    73038
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0687-2016
  • Fecha de inicio del evento
    2015-12-31
  • Fecha de publicación del evento
    2016-01-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142872
  • 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, gamma camera, tomography, computed - Product Code JAK
  • Causa
    To provide operator instruction manuals for the e.Cam dual signature; gamma camera that were not sent in its entirety when the e.Cam systems were refurbished and shipped to the customer.
  • Acción
    An updated Customer Advisory Notice Letter will be provided to each impacted consignee. The receipt of the letter will be documented and additional attempts will be made until such receipt is acknowledged. The Customer Advisory Notice asks that the letter be placed with systems instructions for use along with all provided user documentation. It also advises the consignee to forward the notice to the new customer if the equipment was sold. Customers with questions regarding the Customer Advisory Notice can contact their local Service representative or use the following contact number 1-800-888-7436.

Device

Device Recall e.cam Dual Signature; Gamma Camera
  • Modelo / Serial
    e.cam systems that were refurbished from 04/06/15 to 10/06/15. Material number 10151531, serial number 70004; Material number 10151532 serial numbers 70038, 70040, 70041, 70042, 70043, 70044, 70039, 70045, and 70046.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of Florida, New York, Indiana, Maryland, South Dakota, Missouri, Tennessee, and Georgia, and the countries of Australia and India.
  • Descripción del producto
    The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc., 2501 Barrington Rd, Hoffman Estates IL 60192-2061
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA