Events

Retiro De Equipo (Recall) de Device Recall Radiation Protective Eyewear

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 Phillips Safety Products.

¿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
    48611
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2167-2008
  • Fecha de inicio del evento
    2008-06-05
  • Fecha de publicación del evento
    2008-08-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-12-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71724
  • 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
    Ophthalmic eye shield - Product Code HOY
  • Causa
    Radiation protective eyewear does not meet the radiation protection levels stated on the labeling.
  • Acción
    Customers were all notified by phone, followed by an Urgent Recall letter dated June 3, 2008. The letter asked that customers examine their stock immediately to determine if they had any of these radiation protective bifocals on hand, discontinue use or distribution of the lot, and set the products aside for further instructions. Also, if customers distributed these items, they needed to contact their accounts and advise them of the recall and have them return their outstanding recall stock to them. The firm will send replacement products in the weeks to follow.

Device

Device Recall Radiation Protective Eyewear
  • Modelo / Serial
    ALL radiation protective bifocals, both progressive and FT28 - product numbers: PX-PROG, PX-FT28, FB-103-RXB, FB-500-RXB, FB-100-SRXB, FB-100-BRXB, FB-100-CRXB, FB-108-SRXB, FB-108-BRXB, RGS-97RX-BI, SFFT X-RAY, RGS-53-BI, LT-53-RXP, RG-500-SRG1.5, RG-500-SRG2.0.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- including USA and countries of Spain, Norway, Great Britain and the Netherlands.
  • Descripción del producto
    Radiation Protective Eyewear (only involving multifocals. || FTC 28 Progress X-Ray Protective Eyewear || Protective Eyewear is not sent with any package inserts or labeling. It is sent is plain envelope, bag of box.
  • Manufacturer
    Phillips Safety Products

Manufacturer

Phillips Safety Products
  • Dirección del fabricante
    Phillips Safety Products, 123 Lincoln Blvd, Middlesex NJ 08846-1071
  • Empresa matriz del fabricante (2017)
    Phillips Safety Products Inc.
  • Source
    USFDA