Events

Alerte De Sécurité sur neuro / inspire - surgical planning software

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Renishaw.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2014-11-11
  • Date de publication de l'événement
    2014-11-11
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141111.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: renishaw neuro / inspire - surgical planning software the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning neuro / inspire - surgical planning software (product code: a-5630-3000-a6 and a-5630-3001-a4; software version: 4.0.1665.3; lot numbers: all), manufactured by renishaw. the manufacturer’s internal processes have discovered a bug in neuro inspire v4.0.1665.3 that could potentially result in the software getting into an indeterminate state under certain circumstances. if neuro inspire gets into this state, it may affect surgical planning activities and/or the quality of data produced as an output. this bug may result in a delay to the surgical procedure which in turn may extend the application of general anaesthetic, and risk of infection may also be raised on this basis. the bug may lead to a targeting error that could potentially result in permanent long term injury or life threatening injury to the patient. users should not use the affected products for any clinical procedure until further notice. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con471136 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 november 2014.

Device

neuro / inspire - surgical planning software
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Renishaw neuro / inspire - surgical planning software
  • Manufacturer
    Renishaw

Manufacturer

Renishaw