Events

Retiro De Equipo (Recall) de Device Recall Pinnacle3 Software

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 Electronics North America 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
    71689
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2200-2015
  • Fecha de inicio del evento
    2014-07-31
  • Fecha de publicación del evento
    2015-07-22
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138754
  • 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, nuclear magnetic resonance imaging - Product Code LNH
  • Causa
    Philips, pinnacle radiation treatment planning system version 8.0h, 8.0k, 8.0m, 8.0n, 9 0, 9 2 9 4, 9 6 is being recalled because the dose may be inconsistent with the density of a density-overridden rol.
  • Acción
    Consignees were sent on 7/31/2014 a Philips "Urgent Field Safety Notice" dated 2014-July 20. The letter described the problem, product involved in the recall and the action that should be taken by the customers. For questions contact Customer Care Solutions Center at 1-800-722-9377. UPDATE: A second Philips letter dated 2 July 2015 was sent in August 6, 2015. This letter updated the recall to incorporate the additional products being recalled.

Device

Device Recall Pinnacle3 Software
  • Modelo / Serial
    453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451  UPDATED:  453560446051 [A]  459800096361 [Al 453560446061 IA]  459800096541 [A] 453560446091 [A]  459800096741 [A] 453560446101 [A]  459800096921 [A] 453560446111 [A]  459800097111 [A] 453560446131 [A]  459800097291 [A] 453560446141 [A]  459800097471 [A] 453560446161 [A]  459800097651 [B] 453560446181 [A]  459800097831 [B] 453560446201 [A]  459800098171 [B] 459800089221 [A]  459800098351 [A] 459800091451 [A]  459800109261 [A] 459800138101 [BJ 459800189431 [A) 459800220131 [B] 459800239171 [A] 459800233271 [8] 459800233281 [A] 459800233291 [B] 459800233301 [A] 459800233311 [8] 459800233321 [B] 459800233331 [B] 459800233341 [A] 459800233351 [A] 459800233361 [A] 459800234101 [A] 459800234111 [A] 459800234121 [A] 459800318391 [Al 459800405751 [A] 459800417961 [A] 459800249651 [8] 459800249721 [A] 459800249851 [A] 459800249931 [A] 459800250001 [Al 459800250081 [A] 459800250151 [A] 459800250221 [A] 459800250291 [A] 459800250361 [A] 459800250431 [A] 459800250501 [A] 459800250571 [A] 459800338961 [B] 459800340181 [A] 459800340201 [A] 459800341171 [A] 459800341191 [A] 459800341481 [A] 459800341501 [A] 459800345001 [A] 459800345021 [A] 459800345041 [A] 459800345061 [A] 459800345081 [A] 459800345101 [A] 459800454251 [A] 459800455341 [A] 459800493591 [A] 459800494011 [A] 459800554831 [A] 459800554881 [A] 453560435761 453560434881 453560454791 453560461331 453560461341
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US: All states in the US including DC and PR. OUS: Australia, Austria, Bangladesh, Belgium, Brazil, China, Denmark, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands,New Zealand, Oman, Philippines, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, Viet Nam. UPDATED: Canada, Bulgaria, Egypt, Hungary, Jordan, Luxembourg, Poland, Reunion, Romania, Russia, Sauth Arabia, Turkey.
  • Descripción del producto
    Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451. || UPDATED: || Pinnacle3 Software Version 8.0h, 8.0k, 8.0m, 8.0n.
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Dirección del fabricante
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA