Events

Retiro De Equipo (Recall) de Volcano SpinVision Sterile Equipment Cover

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 Volcano Corp.

¿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
    19957
  • Fecha de inicio del evento
    2016-03-29
  • 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: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Causa
    Potential that the product may be labelled beyond its expiration date. a number of units at the manufacturing facility may have been shipped in a package with an inventory label containing an expiration date that is one or more months later than the correct expiration dates shown on the product's primary and secondary packaging., the primary packaging includes a label on each pouch containing individually packaged products. the secondary packaging, which is also the shipping box, also contains a label identifying the product by part and lot number., the correct expiration dates located on the labels of the primary and secondary packaging for these products is no earlier than march 2018, so prompt attention to this notice will prevent expired product from mistakenly remaining in inventory. while month and year are listed, the shelf life extends through the last day of the listed month.
  • Acción
    Manufacturer to issue advice regarding use

Device

Volcano SpinVision Sterile Equipment Cover
  • Modelo / Serial
    Model: 891BG-10, Affected:
  • Manufacturer
    Volcano Corp

Manufacturer

Volcano Corp
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NZMMDSA