Events

Retiro De Equipo (Recall) de Device Recall Highlow:x

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 Snug Seat 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
    50206
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0651-2009
  • Fecha de inicio del evento
    2008-11-06
  • Fecha de publicación del evento
    2009-01-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-02-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74984
  • 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
    chair - Product Code IMS
  • Causa
    Breakage in the welds was discovered in a section of the chair frame.
  • Acción
    Consignees were notified by letter dated 11/6/2008. Snug Seat sent a repair kit to their retail dealers on 11/18/2008. The kit includes a safety plate, written and video replacement instructions as well as the tools (allen wrench, crescent wrench and two nuts) necessary to make the safety update. Customers were identified using purchase order numbers, and product serial numbers to enable the dealers to identify the purchaser of the product. Due to HIPPA regulations, purchaser information was not available to Snug Seat, Inc. to contact directly. Written notification will be followed up with a telephone call to each dealer to ensure they have received the retrofit kit. Snug Seat will also insure they understand the importance of the kit and how to properly install and document receipt of the update for their customers.

Device

Device Recall Highlow:x
  • Modelo / Serial
    Article numbers 8911605-02, 8911605-02E, 8911606-02, 8911615-02, 8911615-02E and 8911616-02. Manufactured between 8/24/2007 and 10/3/2008.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide.
  • Descripción del producto
    High-low:x frame for the x:panda mechanical chair.
  • Manufacturer
    Snug Seat Inc

Manufacturer

Snug Seat Inc
  • Dirección del fabricante
    Snug Seat Inc, 12801 E Independence Blvd, Stallings NC 28105
  • Source
    USFDA