Events

Retiro De Equipo (Recall) de Philips Briiliance (BR) CT 16-Slice, BR CT 10-Slice Water, BR CT 6-Slice Water, MX8000 Quad, MX8000 Dual, MX8000 Dual EXP, MX8000 IDT and MX8000 IDT 10

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
    15027
  • Fecha de inicio del evento
    2013-07-19
  • 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
    The ct system phantom supplied with the above-listed scanners has a special pin by which the customer can check the low contract (lc) detectability for quality assurance. this pinconsists of a nylon (aculon) body with six smaller lexan pins of 3mm, 4mm, 5mm, 6mm, 7mm and 8mm diameters, which have contrast difference of approximately 1% from aculon., the lc test is performed by visually inspecting the sectionand selecting the smallest detectable lexan pin for a predefined scan protocol as defined in the instructions for use. the manufacturer-recommended procedure is subjective in nature and needs to be performed on several scans and by different people to be reliable., the pin visibility deteriorates over time because of slow water absorption. as the pin visibility deteriorates the test becomes unreliable and inaccurate.
  • Acción
    Instructions for use to be updated

Device

Philips Briiliance (BR) CT 16-Slice, BR CT 10-Slice Water, BR CT 6-Slice Water, MX8000 Quad, MX80...

Manufacturer

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