Events

Retiro De Equipo (Recall) de Schaerer 7300 surgical 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 Schaerer Medical USA 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
    75288
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0371-2017
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149952
  • 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, surgical with orthopedic accessories, manual - Product Code JEB
  • Causa
    The floor locking cylinders contained in the base of the schaerer 7300 model surgical tables were manufactured with the incorrect "o" ring which may cause the cylinder to leak.
  • Acción
    Schaerer Medical sent a Field action letters dated September 27, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The customer is required to complete and return a response form with the number of affected tables and cylinders. All affected cylinders will be replaced in the field and returned to the manufacturer. For questions Quality Assurance at 513-272 -9116.

Device

Schaerer 7300 surgical table
  • Modelo / Serial
    Lot Codes for the four (4) model 7300 Surgical Tables  TFX-1653, TFX1654, TFX1655, TFX1656
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of: CA, CT, FL, IA, IN, MI, MN, MO, OH, PA, and VA Replcement cylinders wre distributed
  • Descripción del producto
    The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable. || Product Usage: || The cylinders are used to lock the surgical table in place.
  • Manufacturer
    Schaerer Medical USA Inc

Manufacturer

Schaerer Medical USA Inc
  • Dirección del fabricante
    Schaerer Medical USA Inc, 675 Wilmer Ave, Cincinnati OH 45226-1802
  • Empresa matriz del fabricante (2017)
    Schaerer Medical Usa Inc.
  • Source
    USFDA