Events

Retiro De Equipo (Recall) de Device Recall Philips Ultrasound QLAB

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 Ultrasound, Inc..

¿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
    68756
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2109-2014
  • Fecha de inicio del evento
    2014-07-09
  • Fecha de publicación del evento
    2014-07-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-11-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128604
  • 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, image processing, radiological - Product Code LLZ
  • Causa
    The qlab a2dq and acmq features have a defect that may use incorrect measurement values under specific conditions.
  • Acción
    Philips Medical Systems notified customers of the voluntary recall by sending a certified URGENT-Medical Device Correction letter, dated 2014 JUL 09, to all US and Canadian consignees. Philips representatives will distribute the letter internationally. Follow-up letters to wholesale customers will be provided and wholesalers are requested to forward copies of recall letters and response forms to their customers. Philips Medical Systems will also have Customer Reply Cards returned for tracking purposes. Customers are directed to call local Philips representative or Philips Customer Service at 1-866-767-7822.

Device

Device Recall Philips Ultrasound QLAB
  • Modelo / Serial
    *****SYSTEM BASED ID OUTSIDE THE US**********  120F-P213FA35-V41E, 279E-Q21384E8-P41D, 3FBF-X2649F25-J4BF,  47FD-Q1FD112B-J3F0, 4A8F-U24EA0B5-R493, 5570-Q20D1AB2-W410,  5D8C-G1FC9BDE-N3EF, 684B-V2122501-R41A, 6DA2-G232AD5C-S45B,  731B-Q1FC2691-V3EE, 808E-P20C3018-I40E, 88AA-T1FBB144-W3ED,  A0CB-I24CCB81-M48F, A0ED-H1F5BC5B-P3E1, AB9B-S236CD11-W463,  BE98-V1E4C83A-P3BF, C6A3-H1FFD0F9-X3F5, CBE9-M24BE0E7-Y48D,  EEFC-Y22FED8E-S455, EF0D-I20465FB-I3FE, F475-U1F966C3-X3E8, and  V49C-R203F0AE-I3FE.  ***********Two units shipped in US and one unit shipped outside the US to distributors do not have serial numbers. There are licensing agreements with these distributors that allows the distributors to create their own licensing and serial numbers and/or tracking information.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of CA, IA, KY, MD, NY, PA, UT, VA, WA and WI. Also distributed in Australia, Belgium, Canada, India, Italy, Japan, South Korea, Netherlands, New Zealand, Spain, Sweden, and Switzerland.
  • Descripción del producto
    QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
  • Manufacturer
    Philips Ultrasound, Inc.

Manufacturer

Philips Ultrasound, Inc.
  • Dirección del fabricante
    Philips Ultrasound, Inc., 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA