Events

Retiro De Equipo (Recall) de 1) FEMTO LDV Z2, 2) FEMTO LDV Z4, 3) FEMTO LDV Z6

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 Ziemer Usa 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
    64966
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0811-2014
  • Fecha de inicio del evento
    2013-04-16
  • Fecha de publicación del evento
    2014-01-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-12-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117554
  • 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
    Laser, ophthalmic - Product Code HQF
  • Causa
    A defect in the controller board can lead to the condenser to the video monitor becoming too warm. this could potentially cause the video monitor to shut off.
  • Acción
    A recall notification letter dated April 16, 2013 was mailed to direct accounts. The letter notified the direct accounts of the problem and advised them that a technician would be arriving at their facility during the week of June 2, 2013 to replace the defective controller board. The technician will also perform preventative maintenance on the device at the same time. Direct accounts are advised to contact Ziemer USA, Inc. at 618-462-9301 if they have any questions about this issue.

Device

1) FEMTO LDV Z2, 2) FEMTO LDV Z4, 3) FEMTO LDV Z6
  • Modelo / Serial
    Serial Numbers: FLM4135, FLM3281, FLM2963, FLM3907, FLM3817
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) including states of: NJ and IL; and Internationally to: Finland, Japan, and Germany.
  • Descripción del producto
    1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface. || 2) The FEMTO LDV Z4 Femtosecond Surgical Laser is an opthalmic surgical laser indicated for use in the creation of the corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that does not enclose a volume of the cornea. || 3) The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that may enclose a volume of the cornea.
  • Manufacturer
    Ziemer Usa Inc

Manufacturer

Ziemer Usa Inc
  • Dirección del fabricante
    Ziemer Usa Inc, 620 East Third Street, Alton IL 62002
  • Empresa matriz del fabricante (2017)
    Ziemer Holding Ag
  • Source
    USFDA