Events

Retiro De Equipo (Recall) de Device Recall Omni Diagnost Eleva

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
    Recall
  • ID del evento
    44910
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0911-2007
  • Fecha de inicio del evento
    2007-07-23
  • Fecha de publicación del evento
    2007-09-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64517
  • 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
    X-Ray System - Product Code IZI
  • Causa
    Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures.
  • Acción
    On 7/23/07 Philips mailed a letter dated July 9, 2007 titled Electronic Product Radiation Warning. The letter advises customers of the issue and asks that customers apply the enclosed cautionary label to the device. The letter also explains that there will be a system modification to be installed. On 8/20/07 the firm sent the same letter, along with a letter dated 8/20/07 to customers thought to have either scrapped their units and the customer had previously indicated they were no longer using the unit. The 8/20/07 letter requested the customer contact Philps if they are currently using the device.

Device

Device Recall Omni Diagnost Eleva
  • Modelo / Serial
    Site numbers 500046, 520020, 521648, 522220, 533112, 533314, 533471, 533530, 535118, 535257, 535924, 539106, 540860, 541490
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Units were distributed to 1543 hospitals and medical centers throughout the US. No international distribution from this firm.
  • Descripción del producto
    Philips Omni Diagnost Eleva
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

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