Events

Retiro De Equipo (Recall) de Device Recall Philips Ingenuity Core 728321

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
    80176
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2274-2018
  • Fecha de inicio del evento
    2018-03-28
  • 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=164780
  • 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
    A problem has been detected in the x-ray tube. the affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
  • Acción
    Urgent Field Safety Notice letters were sent to customers on 3/28/18. The letters did not request any actions to be conducted by the customers. For Brilliance Big Bore/ Ingenuity CT / Ingenuity Core / Ingenuity Corel 28 Customers: A Philips Field Service Engineer will contact you to schedule the FCO updates at your site. Field Change Order (FCO 72800691 and 72800692) will be released to correct the issue. For Ingenuity TF PET/CT Customers: Field Change Order (FCO 88200520 and 88200511) will be released to correct this issue. A Philips Field Service Engineer will contact you to schedule the FCO updates at your site.

Device

Device Recall Philips Ingenuity Core 728321
  • Modelo / Serial
    UDI: (01)00884838059498(21)333169, Serial Number: 333169;  UDI: (01)00884838059498(21)310377, Serial Number: 310377;  UDI: (01)00884838059498(21)310375, Serial Number: 310375;  UDI: (01)00884838059498(21)333171, Serial Number: 333171;  UDI: (01)00884838059498(21)333172, Serial Number: 333172
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The systems were distributed to the following US states: HI, KS, and MO. The systems were distributed to the following foreign countries: Algeria, Austria, Brazil, China, Indonesia, Japan, Kenya, Korea, Mexico, Poland, Turkey, and Uganda.
  • Descripción del producto
    Philips Ingenuity Core 728321
  • 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