Events

Retiro De Equipo (Recall) de Uninterruptible Power Supply (UPS) for Philips CT / Advanced Molecular Imaging Systems

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Philips Medical Systems (USA).

¿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
    18335
  • Fecha de inicio del evento
    2015-04-09
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Causa
    Philips has become aware of ups device failures that resulted in leaking of electrolyte (sulfuric acid), overheating and/or emission of fumes. analysis has identified that these failures are most likely due to batteries within the ups devices being held in service beyond their usable service life - typically three to five years.
  • Acción
    Manufacturer to issue advice regarding use

Device

Uninterruptible Power Supply (UPS) for Philips CT / Advanced Molecular Imaging Systems
  • Modelo / Serial
    Model: BrightView X / XCT, Cardio MD, Forte, Gemini TF/ GXl (6 slice) / TF Astonish / 16 Power / GXL / TF 64 w/ TOF Performance, Precedence, Brilliance CT 16 Slice Air / 64 Channel / Big Bore / iCT / iCT - BETA TEST SYSTEM / iCT SP, Ingenuity CT / Core / Core128, Affected: All units
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

Philips Medical Systems (USA)
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NZMMDSA