Events

Retiro De Equipo (Recall) de Device Recall Cmax 110v Surgical Table Hand Control

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 Steris Corp.

¿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
    52172
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1599-2009
  • Fecha de inicio del evento
    2009-05-12
  • Fecha de publicación del evento
    2009-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82394
  • 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, ac-powered - Product Code FQO
  • Causa
    A limited quantity of the cmax hand controls, p150832-500, were manufactured without loctite thread locker on the screws that attach the mounting clip to the hand control case. this clip provides a means of storing the hand control on the table side rails. it is possible that screws without loctite can work loose and the clip can become separated from the hand control. if both screws back out c.
  • Acción
    Steris Corp. issued an "Urgent Product Correction" notice dated May 12, 2009 informing consignees of the affected device and that a Steris Service Representative with be in contact to make the necessary inspection and repairs to the device. Steris Field Service Dispatch can be reached at 1-800-288-2805. For further questions, contact Steris at 1-800-548-4873 extension 27318.

Device

Device Recall Cmax 110v Surgical Table Hand Control
  • Modelo / Serial
    Model Number(s): 2182625; Serial Numbers: AC0001 to AC0221.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- U.S. states of AL, AR, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WI and WV and countries of Canada and Taiwan.
  • Descripción del producto
    Cmax 110v Surgical Table Hand Control. || The Cmax Surgical Table is a mobile, electro-hydraulically operated || surgical table designed to support all general surgical procedures, with the || addition of STERIS table accessories. Tabletop positioning and || articulations are controlled via the hand control.
  • Manufacturer
    Steris Corp

Manufacturer

Steris Corp
  • Dirección del fabricante
    Steris Corp, 5960 Heisley Rd, Mentor OH 44060
  • Source
    USFDA