Retiro De Equipo (Recall) de CARINAsim and CARINAiso

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 LAP of America Laser Applications, LLC.

¿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
    68266
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1709-2014
  • Fecha de inicio del evento
    2013-10-07
  • Fecha de publicación del evento
    2014-06-03
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2016-09-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
  • Causa
    Potential for patient to be marked incorrectly. customers currently using carinasim or carinaiso systems can encounter two safety relevant errors in the operating instructions (carinasim man-1236 rev 2 / carinaiso man-1237 rev 2).
  • Acción
    On 10/16/2013 Customers were sent an Urgent field safety notice for Corrective action concerning the operating instructions of CARINAsim and CARINAiso. The letter identified the affected product, as well as the issues involved. Users were to review their current operating steps and validate their operating sequence. Users should have received a modified software version with software update in February 2014. All users should have been notified of this letter and a copy should be maintained in the users' records. Questions should be directed to Thomas Gaudet on 561-416-9250 at the Service Center.

Device

  • Modelo / Serial
    CARINAiso = Part # 0007536-0001  CARINAsim = Part #0007535-0002
  • Distribución
    Worldwide Distribution -- USA, including the states of AK, AZ, CA, CT, DC, FL, GA, IA, ID, IL, KS, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WY and the territory of Puerto Rico; and, the countries of Brazil, Canada, Chile, Colombia, Cuba, Honduras, and Mexico.
  • Descripción del producto
    CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    LAP of America Laser Applications, LLC, 161 Commerce Rd Ste 3, Boynton Beach FL 33426-9385
  • Source
    USFDA