Events

Retiro De Equipo (Recall) de Device Recall Philips Healthcare Allura XPER FD20

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
    57106
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1369-2011
  • Fecha de inicio del evento
    2010-11-04
  • Fecha de publicación del evento
    2011-03-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-07-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97839
  • 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
    Angiographic X-Ray System - Product Code IZI
  • Causa
    Adjustment of the micro-switches in the footswitch used on the philips cardiovascular x-ray systems was not implemented. if it is programmed for exposure, it is possible that after pressing the pedal on the footswitch it does not release itself. the patient may be exposed to x-ray longer than intended.
  • Acción
    On 11/5/10, Philips began sending the Electronic Product Radiation Warning notification letter, dated November 4, 2010, to their consignees. The consignees were informed that the middle pedal of the foot switch of the Allura FD10, FD20, CV20 systems, and the Allura Field Extension series does not not always become inactive (sticks) when pedal is released. The function of the middle pedal on the foot switch is freely programmable by the customer. If it is programmed for exposure and if the pedal does not release by itself, the patient will be exposed to X-ray longer than intended. The consignees were advised to check if their footswitch is possibly affected. Footswitch identification 452270000141 is noted. If the pedal does not release by itself press the red emergency stop button on the system. Consignees can call Philips Healthcare Call Center at 800-722-9377, #5 and Reference FCO 72200189.

Device

Device Recall Philips Healthcare Allura XPER FD20
  • Modelo / Serial
    Site Numbers: 103331, 520481, 537743, 43721190, 43796227, 51126900, and 51333259.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, including states of CA, IL, MA, NC, and OC.
  • Descripción del producto
    Allura XPER FD 20 and and Allura CV20; || Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura CV20. || Angiographic X-ray systems with a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
  • 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