Events

Retiro De Equipo (Recall) de Device Recall Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07)

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 Reliance Medical Products 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
    79601
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1318-2018
  • Fecha de inicio del evento
    2017-12-06
  • 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=162749
  • 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
    Refractor, manual, non-powered, including phoropter - Product Code HKN
  • Causa
    Product has been found with a missing washer, retaining ring, and/or stop screw. recalling firm was notified by distributor that refractor suspension arm fell on a patient s lower torso along with the arm housing.
  • Acción
    Recalling firm sent letter to customers via certified mail for US customers and via regular mail to foreign customers. Verify product has the presence of the one or more of the three parts: Refractor Suspension Arm missing Screw, Washer and/or Retaining Ring (Snap Ring) that may be missing, and to assure it is functioning properly. For further questions, please call (513) 398-3937

Device

Device Recall Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07)
  • Modelo / Serial
    Model Number: 525004, 05 and 525006, 07
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA(nationwide) Distribution to the states of : NJ, CA, OH, VA, MA, MN, IL , UT, TN, AR, LA, AZ, PA, TX, IA and HI., and to the countries of : Costa Rica, Jamaica, South Africa, New Zealand, South Korea, Dubai, Saudi Arabia and Jordan.
  • Descripción del producto
    Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) || The Intended use of this medical device, as part of system to store and position ophthalmological examination and diagnostic equipment, is to store and position for examination a device commonly known as a refractor.
  • Manufacturer
    Reliance Medical Products Inc

Manufacturer

Reliance Medical Products Inc
  • Dirección del fabricante
    Reliance Medical Products Inc, 3535 Kings Mills Rd, Mason OH 45040-2303
  • Empresa matriz del fabricante (2017)
    Metall Zug AG
  • Source
    USFDA