Retiro De Equipo (Recall) de Device Recall EasyDiagnost Classic

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 Philips Medical Systems North America Co. Phillips.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Radiographic Tilting Table - Product Code IXR
  • Causa
    Potential for the tower (holding the serial changer and/or image intensifier) to slide unexpectedly and potentially injure a patient or user in its path.
  • Acción
    On 1/4/08, the firm issued the URGENT PRODUCT CORRECTION letter dated 1/3/08 to their consignees via certified mail, return receipt requested. The letter informs consignees the issue of the safety switch and counter weight steel band on the Diagnost 55/66/76Plus, Easy Diagnost, and Easy Diagnost Eleva X-ray systems. However, the Easy Diagnost Eleva X-ray system was distributed and applied only to foreign consignees outside US. If the consignees hear the primary steel band clicking/rattling noise while tilting the table to 90 degrees table or positioning the serial changer, the consignees are instructed to tilt the table base towards the 0 degree tilting position and do not use the tilting drive movement until the mandatory action by a Philips service representative has been performed. The Field Change Order (FCO) would be implemented on 01/23/08 and expected to be completed by July 2008. The firm's representatives will visit sites and will inspect all systems where the switch has been replaced or adjusted for proper operation of the safety sensor and switch. Two steel bands will be inspected and replaced if any abnormity is noted. In the mean time, consignees should contact Philips Call Center at 800-722-9377, #5, #2 and reference the FCO 70600029 with any questions.


  • Modelo / Serial
    Device is identified as Site number 86389.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    EasyDiagnost Classic has a radiographic tilting table. This system has a cassette film option and it does not have a Digital Spot Imaging (DSI) system. || Intended use is for the following applications: as a multifunctional/universal system, general R/F, Fluoroscopy, Radiology, and Angiography can be performed along with pediatric examinations and more specialized interventional applications.
  • Manufacturer


  • Dirección del fabricante
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source