Events

Retiro De Equipo (Recall) de Device Recall Hamamatsu Microfocus Xray Source

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 Hamamatsu Corporation.

¿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
    60991
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1224-2012
  • Fecha de inicio del evento
    2011-03-30
  • Fecha de publicación del evento
    2012-03-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-01-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106996
  • 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
    Industrial x-ray - Product Code RBS
  • Causa
    It was discovered that the micro focus x-ray source could be experiencing software related problems that would allow the unit to exceed the maximum power setting that was set by the operator.
  • Acción
    Hamamtsu Corporation sent a Warning letter dated December 22, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. CDRH approves your CAP under the following conditions: 1. Hamamatsu is able to work with your manufacturer customers to assure the revised manual and new label are provided to your customers' end users. 2. Hamamatsu informs CDRH if you receive information which indicates this control defect has occurred. Relevant information includes direct communication from customers or through observation of excessive wear on returned x-ray tubes. For questions regarding this recall call 908-231-0960, ext 2300.

Device

Device Recall Hamamatsu Microfocus Xray Source
  • Modelo / Serial
    Series L8601, L9121, L7901, and L8031
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-- USA (nationwide) and the country of Canada.
  • Descripción del producto
    Hamamatsu Corporation, Bridgewater NJ 08807 || Microfocus X-ray Source || L8601 series, L9121 series (90kV type MICROFOCUS X-RAY SOURCE), || L7901 series, and L8031 series (100kV type MICROFOCUS || x-ray source
  • Manufacturer
    Hamamatsu Corporation

Manufacturer

Hamamatsu Corporation
  • Dirección del fabricante
    Hamamatsu Corporation, 360 Foothill Rd, Bridgewater NJ 08807
  • Empresa matriz del fabricante (2017)
    Hamamatsu Photonics K.K.
  • Source
    USFDA