Events

Retiro De Equipo (Recall) de Device Recall Lockheed Martin Aculight Capella R1850 Laser

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 Lockheed-Martin Aculight.

¿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
    57473
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2069-2011
  • Fecha de inicio del evento
    2010-11-19
  • Fecha de publicación del evento
    2011-05-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96310
  • 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
    Veterinary laser - Product Code RGB
  • Causa
    It has been determined that there are certain software driven operating sequences involving off-on cycling of the key-switch that do not result in a reset of the stim enable button, and emissions can resume after a standard 5 second countdown without pressing this button a second time.
  • Acción
    On 11/22/10, Lockheed Martin Aculight sent a Memo to their Customers and Users informing them of the "Stim Enable" button reset error. The defect involves the function of the "Stim Enable" button on the front panel of the Capella R-1850. In December 2010, the firm sent a second lletter with instructions on how to return the Capella R-1850 Laser back for repair. The firm's plan to correct the defect involved removal of existing software, installation of revised software, and documented verification testing, per written instructions, to confirm resolution of the Stim-Emit button failure to reset. Corrections were to be made at no cost to the customer. A Lockheed Martin Aculight customer service representative will contact you shortly and provide detailed information on how to return the Capella-R 1850 laser product in your possession for testing and repair on this defect. Should you have any questions, please call (425) 482-1100.

Device

Device Recall Lockheed Martin Aculight Capella R1850 Laser
  • Modelo / Serial
    SERIAL NUMBERS: 2, 3, 4, 5, 7, 8, 9, 10, 11, 12, 13, 107, 1031, 1032, 1041, 1065, and 1071.
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    Devices were distributed Universities, Institute, and government consignees in CT, IL, MA, MD, OH, TN, TX, and UT. One unit was distributed to Germany.
  • Descripción del producto
    Lockheed Martin Aculight Capella-r 1850 Laser. This device has the Accession number 0612339. || The Capella R-1850 is a Class 4 solid state diode laser product designed to emit 1850mn laser radiation at maximum pulse energy of 5 mJ (@1ms). The output port connects to a user-selected 200-600 micron diameter optical fiber. || The Capella R-1850 is labeled in part: "***LASER APERTURE***Aculight Corporation 22121 20th ave SE Bothell, WA 98021***Feb 2007***Model R-1850, SN: 007***".
  • Manufacturer
    Lockheed-Martin Aculight

Manufacturer

Lockheed-Martin Aculight
  • Dirección del fabricante
    Lockheed-Martin Aculight, 22121-20th Ave SE, Bothell WA 98021
  • Empresa matriz del fabricante (2017)
    Lockheed Martin Corporation
  • Source
    USFDA