Events

Retiro De Equipo (Recall) de Device Recall Ziehm Solo FD

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 Ziehm Imaging 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
    77030
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1893-2017
  • Fecha de inicio del evento
    2017-02-23
  • 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=154847
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Causa
    During ziehm imaging gmbh fda inspection, the label for the collimator and x-ray control panel was missing the manufacturer date as part of the identification for certified component.
  • Acción
    Ziehm Imaging will bring defect into compliance: Customer Precautions: Therefore, as there is no identifiable risk to patients, users or third parties, the manufacturer Ziehm Imaging GmbH advises customers they may continue to operate the affected device until the labeling materials can be remediated. Please alert all staff members working with the device to this notification. Remedy: 1. You will contact customers and initiate the actions to correct the failure to comply issues. 2. You will affix the identification labels to the collimator and x-ray control panel. 3. You will replace the existing user manual with one that reflects the reference images of the labels with manufacturer date. If there are any questions or concerns regarding this product safety issue, please do not hesitate to contact our National Service Team for further information at Ziehm Imaging, Inc. Toll-Free: (866) 949-4346, Fax: (866) 839-7893 or E- Mail: customerservice@ziehm.com

Device

Device Recall Ziehm Solo FD
  • Modelo / Serial
    S/N 52199, 52108
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : FL and CA. No devices listed in this recall where distributed any foreign /military/government consignees from the U.S.A.
  • Descripción del producto
    Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
  • Manufacturer
    Ziehm Imaging Inc

Manufacturer

Ziehm Imaging Inc
  • Dirección del fabricante
    Ziehm Imaging Inc, 6280 Hazeltine National Dr Ste 100, Orlando FL 32822-5114
  • Empresa matriz del fabricante (2017)
    Aton 2 Gmbh
  • Source
    USFDA