Events

Retiro De Equipo (Recall) de Radiolucent Spine Surgery Frame

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 Allen Medical Systems.

¿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
    79205
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0642-2018
  • Fecha de inicio del evento
    2017-10-06
  • 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=161648
  • 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 base of the frame has the potential to crack when the patient is initially transferred to the bow frame.
  • Acción
    In October of 2017 an Urgent Medical Device Correction letter was sent to customers notifying them of the recall and requesting customers to immediately remove any frames from use that are in the serial number range subject to the recall and that a service technician will coordinate correction of the device. If the device was sent to another company, to forward the recall notice o that person or firm. If you have any questions concerning this Urgent Medical Device Correction, please contact Allen Medical Customer Service at (800) 433-5774, 8:30  5:00 pm EST.

Device

Radiolucent Spine Surgery Frame
  • Modelo / Serial
    Serial Number: 533552 536025 536451 539585 539795 535272 536026 536452 539586 542764 535273 536027 536453 539587 544938 535274 536028 536454 539588 544939 535386 536029 536455 539589 544940 535387 536030 536456 539794 546200
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution. US Nationwide, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Netherlands, Spain, Switzerland, Taiwan, UAE, and UK.
  • Descripción del producto
    Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
  • Manufacturer
    Allen Medical Systems

Manufacturer

Allen Medical Systems
  • Dirección del fabricante
    Allen Medical Systems, 100 Discovery Way, Acton MA 01720-4481
  • Empresa matriz del fabricante (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA