Events

Retiro De Equipo (Recall) de Device Recall CRYO Care Surgical System

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 Healthtronics, 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
    57924
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1275-2012
  • Fecha de inicio del evento
    2012-02-27
  • Fecha de publicación del evento
    2012-03-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97760
  • 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
    Unit, cryosurgical, accessories - Product Code GEH
  • Causa
    Healthtronics has initiated this recall of these products because there have been instances where the temperature probes (aka tempprobes) in the kit may be mislabeled. in some instances, the label near the prove does not match the label at the connector. if the labeling error went undetected, the tempprobes would not be monitoring temperature in the area believed to be under surveillance.
  • Acción
    Endocare sent an Urgent: Device Recall letter dated February 27, 2012 to all affected consignees. The letter identified the affected product, problem and actions to be taken. The letter instructed consignees to immediately cease all distribution, examine their stock and the stock of accounts that have been supplied and remove any affected devices from all inventories. If the product have been further distributed contact Endocare for instruction. If consignees have any of the affected products: 1) Contact Customer Service at 877-367-4873 to obtain a RMA number, 2) Complete the Verification Section on page two, and 3) Return this letter with the affected product to the address provided. For questions about this recall contact Endocare, Inc at 877-367-4873.

Device

Device Recall CRYO Care Surgical System
  • Modelo / Serial
    Multiple codes.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) and the countries of Barbados, Brazil, Canada, China, Italy, Jakarta, Malaysia, Madrid Spain, Taiwan, and United Kingdom.
  • Descripción del producto
    CRYO-206V and CRYO-206F Procedure Kit, which includes: Cryo Probes, Urethral Catheter, and temperature probes. || Kit is intended to be used with the CryoCare Surgical System for freezing/ablating tissue by extreme cold temperatures.
  • Manufacturer
    Healthtronics, Inc.

Manufacturer

Healthtronics, Inc.
  • Dirección del fabricante
    Healthtronics, Inc., 9825 Spectrum Dr Bldg 2 # 275, Austin TX 78717-4929
  • Source
    USFDA