Events

Retiro De Equipo (Recall) de Magnus Hybrid operating table columns

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 Maquet 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
    60344
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0389-2012
  • Fecha de inicio del evento
    2011-09-19
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105069
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
    Table, operating room, ac powered - Product Code LFQO
  • Causa
    A component of the magnus hybrid or system fails to respond to a position command.
  • Acción
    Maquet sent a PRODUCT RECALL URGENT MEDICAL DEVICE CORRECTIVE ACTION letter dated September 19, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. To avoid the potential of a malfunction occurring prior to their scheduled Service procedure, customers were instructed to ensure that the MAGNUS table-top is positioned at the "0" pivot position and that the MAGNUS column pivot brake is secured. If it is necessary to pivot the MAGNUS table-top prior to procedure start, ensure that the column pivot brake is completely released and then completely secured when returned to "0" pivot position. Customers were instructed to ensure that all user of the affected product and other necessary persons are informed of the product correction notice. For technical support or questions call 1-888-627-8383

Device

Magnus Hybrid operating table columns
  • Modelo / Serial
    510 k EXEMPT  1180.01A1- Lot #0002, 0004, 0005, 0007-00011, 00013- 0017, 00019-00029, 00001  1180.01B1- lOT #00001, 00002, 00005-00012, 00014, 00015, 00017, 00018
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including VA, LA, MO, NC, MD, and AZ and the countries of AE, AU, CA, CH, CN, DE, DK, ES, IE, IL, SP, PL, RU, and TH.
  • Descripción del producto
    Magnus Hybrid operating table columns 1180.01A1 and 1180.01B1
  • Manufacturer
    Maquet Inc.

Manufacturer

Maquet Inc.
  • Dirección del fabricante
    Maquet Inc., 45 Barbour Pond Drive, Wayne NJ 07470
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA