Events

Retiro De Equipo (Recall) de Solea 1.0

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 Convergent Dental.

¿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
    66361
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0050-2014
  • Fecha de inicio del evento
    2013-09-12
  • Fecha de publicación del evento
    2013-10-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-11-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122154
  • 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
    CO2 laser - Product Code GEX
  • Causa
    Specific error condition could lead to unintended laser emission during laser activation.
  • Acción
    The following Notice of Correction letter was sent out to all customers via email on 9/12/13, and followed up with a direct phone call to confirm receipt and review the contents of the letter: Dear Dr. [Customer name], This email is to inform you of a pending notice of correction regarding your Solea system, serial #[Customer serial number]. We have identified a specific error condition that could lead to unintended laser emission during laser activation. The software defect that caused the error condition has been identified and tested. Please do not use your Solea system until further notice. Resolution of this issue will require the installation of an updated release of the Solea software. A representative from Convergent Dental will be in touch with you to schedule the upgrade. Convergent Dental is committed to product quality and patient safety. If you have questions about this issue, please contact us. Software fix and testing: New software version (Release 2.0.4.0) was created by the software development group. Convergent Dental has implemented two software changes to eliminate this problem. The first is a defect fix to correct the handling of fatal errors, specifically laser communication timeout errors, so that these errors are not able to be cleared. This will prevent the user from being able to re-enter the workflow after a fatal error. The second is a defect fix to not set the laser state to disconnected when a laser timeout error condition occurs. This will ensure that the command to stop laser emission is always sent to the laser control module anytime the laser cutting state is exited due to error condition or the normal workflow event of stepping off the foot pedal. The software development team ran full Unit and Integration Tests on the new software build. The software verification activities included execution of the full verification test plan (Doc #790-00001), which has been revised to include specific defect

Device

Solea 1.0
  • Modelo / Serial
    Serial Numbers: CDS1-DVSU-1B-JU-13; CDS1-7QRE-1B-JU-13; CDS1-22TZ-1B-JU-13; CDS1-PNJZ-1B-AU-13; CDS1-A4CQ-1B-AU-13
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US distribution including states of: MA, CT, NY.
  • Descripción del producto
    Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
  • Manufacturer
    Convergent Dental

Manufacturer

Convergent Dental
  • Dirección del fabricante
    Convergent Dental, 2 Vision Dr, Natick MA 01760-2086
  • Source
    USFDA