Events

Retiro De Equipo (Recall) de Device Recall MEDRAD MRXerion MR Injection 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 Bayer Healthcare.

¿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
    74513
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2244-2016
  • Fecha de inicio del evento
    2016-06-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147806
  • 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
    Injector and syringe, angiographic - Product Code DXT
  • Causa
    Bayer healthcare is initiating this recall due to complaints that were received from customer sites describing a 4205 error message when the injector is used with a 3t scanner.
  • Acción
    Bayer sent an Urgent Medical Device Field Corrective Action letter dated June 8, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to take the following steps should a 4205 error message is encountered. For questions contact Bayer Customer Support Team at 1-800-633-7237.

Device

Device Recall MEDRAD MRXerion MR Injection System
  • Modelo / Serial
    Catalog numbers: MRXP 200 Serial numbers: 100009, 100011, 100019, 100020, 100022, 100026, 100027, 100028, 100036, 100047, 100065, 100066, 100069, 100074, 100075, 100085, 100090, 100091, 100096, 100097, 100098, 100099, 100100, 100101, 100103, 100104, 100106, 100107, 100108, 100109, 100110, 100111, 100112, 100113, 100114, 100118, 100119, 100129, 100152, 100155, 100161, 100166
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide and the US state of NEW YORK
  • Descripción del producto
    Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit || Usage: || The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) applications with MRI scanners that have a magnetic field strength between 0.7 and 3.0 Tesla. Only trained healthcare professionals are intended to operate this device.
  • Manufacturer
    Bayer Healthcare

Manufacturer

Bayer Healthcare
  • Dirección del fabricante
    Bayer Healthcare, 1 Bayer Dr, Indianola PA 15051-9702
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    USFDA