Events

Retiro De Equipo (Recall) de Device Recall Philips Healthcare Brilliance 64

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 Philips Medical Systems (Cleveland) 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
    78852
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0389-2018
  • Fecha de inicio del evento
    2017-11-10
  • 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=160868
  • 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
    System, x-ray, tomography, computed - Product Code JAK
  • Causa
    Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. if the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
  • Acción
    An Urgent - Field Safety Notice Medical Device Correction letter, dated November 1, 2017, was sent to customers. The letter identified the affected device, described the issue, and discussed the hazard involved. Users are to cease use immediately and contact their Philips Field Service Engineer, if any unusual noises are heard within the gantry, or if the patient support tabletop is in free float. Philips Field Service Engineers will correct the system by replacing the affected fasteners. If further info or support concerning this issue is needed, customers can contact their local Philips rep or the Customer Care Solutions Center at 1-800-722-9377.

Device

Device Recall Philips Healthcare Brilliance 64
  • Modelo / Serial
    Code 728231, SN # 10655
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign accounts
  • Descripción del producto
    Brilliance 64, (Code 728231) || Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Dirección del fabricante
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA