Events

Retiro De Equipo (Recall) de Artemis Software Apps for Clinician Programmer (Model 3874)

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 St Jude Medical (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
    21996
  • Fecha de inicio del evento
    2017-09-19
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Causa
    The manufacturer is advising customers that it is aware of instances in which the elective replacement indicator (eri) in some devices has triggered earlier than intended. in these cases, the eri alerts were triggered early due to an error in how the device calculates the actual remaining battery life in the impacted implantable pulse generators (ipg). eri alerts estimate battery life based on programmed device parameters and patient usage and are unique to each patient. it is important to be aware that this issue is an error in software calculation and is not an indication of the devices' actual battery performance.
  • Acción
    Software to be upgraded

Device

Artemis Software Apps for Clinician Programmer (Model 3874)
  • Modelo / Serial
    Model: , Affected: Clinician Programmer and Patient Controller and Proclaim IPG implantable pulse generator
  • Manufacturer
    St Jude Medical (USA)

Manufacturer

St Jude Medical (USA)
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NZMMDSA