Events

Retiro De Equipo (Recall) de Device Recall Rotating IV Pole

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 Ohmeda Medical.

¿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
    79452
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1181-2018
  • Fecha de inicio del evento
    2017-12-01
  • 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=162347
  • 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
    Stand, infusion - Product Code FOX
  • Causa
    There is the potential for the rotating iv pole to fall. a fall could result in an injury to a bystander holding the patient or to the operator.
  • Acción
    On December 1, 2017 an URGENT MEDICAL DEVICE CORRECTION letter was issued to customers notifying of the recall. The letter requested customers to discontinue use of the affected Rotating IV poles and remove from Service. Place affected Rotating IV poles in a quarantine marked area. A GE Service Representative will contact you to arrange for the removal & replacement of a new IV pole. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. For further questions, please call (410) 888-5376.

Device

Device Recall Rotating IV Pole
  • Modelo / Serial
    Model Number(s): 6600-0851-800 Affected lot codes are within LAU13921134 - LAU14720444
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    USA (nationwide)
  • Descripción del producto
    Rotating IV Pole || Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate attachment and consolidation of patient equipment to one central patient care area. Devices commonly attached to IV poles include IV pumps, feeding pumps, and infusion fluid bags. Products used on: Giraffe OmniBed, Giraffe Warmers, Panda Warmers and Giraffe Incubators and Giraffe Shuttle. The IV pole also can be mounted to the Care Plus Incubator and Panda IWS.
  • Manufacturer
    Ohmeda Medical

Manufacturer

Ohmeda Medical
  • Dirección del fabricante
    Ohmeda Medical, 8880 Gorman Rd, Laurel MD 20723-5800
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA