Events

Retiro De Equipo (Recall) de HIVISION Preirus, Avius ultrasound systems

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
    58703
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2467-2011
  • Fecha de inicio del evento
    2011-04-18
  • Fecha de publicación del evento
    2011-06-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100089
  • 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, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Causa
    Software anomaly. the doppler trace measurement feature on certain models of the firm's diagnostic ultrasound systems, may, under certain conditions whereby multiple measurements are done sequentially, record incorrect values. the recorded value is displayed to the user on a report; however depending upon the measurement area, displayed velocity values could be lower than at the true velocity lead.
  • Acción
    The firm, Hitachi, sent a "DEVICE CORRECTION NOTICE" letter dated April 15, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were inform of the nature of the software error in the Doppler Trace Measurement feature; the circumstances under which this error can occur; and the safety issue involved should incorrect values generated lead to a false diagnosis of stenosis in a patient. The letter provides the customer with a workaround solution in order to avoid this issue. The customer were also instructed to call the HMSA Applications Helpline at 877-871-2777 to reprogram their system to temporarily eliminate the noted safted issue and to immediately have all selections unchecked on the Doppler trace measurement result store setting set up screen. The notification letter also states that Hitachi Medical Systems America (HMSA) will be having their service personnel schedule a visit at each customer location and install a software upgrade on each affected system unit in order to directly address, and permanently resolve this issue. If you need any further information regarding this notice, please contact the Manager of Regulatory Affairs at 800-800-3106 x3720 or email to: thistlewaited@hitachimed.com.

Device

HIVISION Preirus, Avius ultrasound systems
  • Modelo / Serial
    All codes manufactured from 11/2/2009 to 3/4/2011, are subject to recall. Preirus (KE10584001-KE17585003)/Avius (KE11088001-KE11476102)
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of: CA, MD, KY, FL, MN, NJ, IA, OH, TX, IL, and IA.
  • Descripción del producto
    Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software - Doppler Trace Measurement program. 510 (k) Numbers: Preirus - K093466 (6/1/10), Avius - K102901 (10/27/10). || The Preirus and Avius are intended for use by trained personnel (doctors, sonographers, etc) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Feta, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Genecology, Urology and Laparoscopic clinic applications. The Modes of Operation of the HIVISION Preirus are B mode, M mode PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler) Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, RealTime Tissue Elastography, and Real Time Virtual Sonography.
  • 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