Events

Retiro De Equipo (Recall) de Device Recall Hi Vision ultrasound diagnostic scanners

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 Hitachi Medical Systems America 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
    52434
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2054-2009
  • Fecha de inicio del evento
    2008-05-12
  • Fecha de publicación del evento
    2009-09-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-07-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82981
  • 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
    Diagnostic ultrasonic transducer - Product Code ITX
  • Causa
    The firm's parent company discovered a dicom uid (universal identifier) code mix-up which can occur due to a software error. this error can cause the images from two (2) different patient scans to become intermingled and consequently, labeled incorrectly.
  • Acción
    HMSA issued a 'DEVICE CORRECTION' notification to their customers on 5/12/2008. The notification describes the potential data transmission problem (potential to archive studies done on different patients into the same patient folder) and the conditions under which this problem can occur. The notification cautions the user/customer to verify all images stored on the PACS (Picture Archiving and Communications System) in order to ensure that they do not contain images from a different patient. The DEVICE CORRECTION letter also states that the firm will be installing updated software on all affected systems beginning in June, 2008, in order to address this issue. It also states that a Hitachi Service Rep. will be contacting each customer and making arrangements to set up a convenient time to come out and perform a software upgrade. Lastly, the letter provides a toll-free telephone # to the firm's 'Customer Service Center: 1-800-800-4925, which the customer can use to obtain additional information, if desired.

Device

Device Recall Hi Vision ultrasound diagnostic scanners
  • Modelo / Serial
    The following Serial Numbers for this device were subject to recall/software correction: 17094308, 17094309, 17150307, 17350302, 17094305, 17869402, 18435403, 18435404, 17492302, and 17204305.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The recalled device system units were distributed to customers located in the following states within the U.S ony.: AR, CA, and TX.
  • Descripción del producto
    EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A.
  • Manufacturer
    Hitachi Medical Systems America Inc

Manufacturer

Hitachi Medical Systems America Inc
  • Dirección del fabricante
    Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087
  • Empresa matriz del fabricante (2017)
    Hitachi Ltd
  • Source
    USFDA