Events

Retiro De Equipo (Recall) de Skytron EZ Slide Operating Table

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 Skytron, Div. The KMW Group, 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
    74128
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1844-2016
  • Fecha de inicio del evento
    2016-04-06
  • Fecha de publicación del evento
    2016-05-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146394
  • 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
    Table, operating-room, electrical - Product Code GDC
  • Causa
    The potential exists within the identified tables that incorrectly manufactured parts have been used in assembly. if a table is found to have these incorrectly manufactured parts, it is possible for the tables elevation column slide cap to become detached from the elevation column and could result in the loss of control of the table top and injury to the patient or staff.
  • Acción
    Skytron sent an Urgent Medical Device Recall letter dated A,pril 4, 2016, to all affected customers. On April 6, 2016, URGENT: Medical Device Recall notifications were sent to the affected hospitals and distributors via certified mail. The notification instructed the hospital to identify and remove the affected product from use. The notification instructs the distributor to contact the hospital to schedule replacement. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities. The notification did not include instructions for responding to the formal recall notification, however the company did request acknowledgement via follow-up email. Please call Technical Services, at 616-656-1187 or 616-656-6403 with any questions. For after-hours support, please call 1-800-SKYTRON.

Device

Skytron EZ Slide Operating Table
  • Modelo / Serial
    Model number 3502. All units. Units entered commercial distribution between April 30, 2014 and July 24, 2014
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to AL, AZ, CO, IA, WI, PA, TN, MA, TX, MI, FL, MS, LA, and CA.
  • Descripción del producto
    EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide || General Purpose Surgical Table || Skytron EZ Slide Operating Table || General Purpose Surgical Table
  • Manufacturer
    Skytron, Div. The KMW Group, Inc

Manufacturer

Skytron, Div. The KMW Group, Inc
  • Dirección del fabricante
    Skytron, Div. The KMW Group, Inc, 5085 Corporate Exchange Blvd SE, Grand Rapids MI 49512-5515
  • Empresa matriz del fabricante (2017)
    The Kmw Group Inc
  • Source
    USFDA