Events

Retiro De Equipo (Recall) de Device Recall Raymond Corporation ForkTip Laser Guide

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 The Raymond 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
    60528
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0484-2012
  • Fecha de inicio del evento
    2011-11-28
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • 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=105699
  • 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
    Alignment laser product - Product Code RER
  • Causa
    Raymond shipped a laser alignment guide as an option on its powered industrial trucks from february 2, 2010 through april 21, 2011, but was not aware of its obligation under 21 c.F.R. 1010.2 and 1010.3 to certify and label.
  • Acción
    Raymond will be initiating a Field Campaign to ensure that all customers with Alignment Guides have the confirmatory laser caution decals and manufacturer label, an updated installation and service manual, the operator instructions, and informational brochure. This campaign will be performed at no cost to Raymond's dealers and customers, and will include documenting the laser serial number for each truck configured with an Alignment Guide for product traceability.

Device

Device Recall Raymond Corporation ForkTip Laser Guide
  • Modelo / Serial
    Model #1096597/001
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Raymond Laser alignment guide - Model #1096597/001 Green Laser. || Intended to assist operators in performing material handling activities such as storing and retrieving pallets and material in and on racking projecting a line onto a pallet or other material storage medium for assisting the operator in determining the position of the powered industrial truck forks with respect to load.
  • Manufacturer
    The Raymond Corporation

Manufacturer

The Raymond Corporation
  • Dirección del fabricante
    The Raymond Corporation, S Canal St, Greene NY 13778-1281
  • Empresa matriz del fabricante (2017)
    Toyota Industries Corporation
  • Source
    USFDA