Events

Alerte De Sécurité sur Cranial Navigation System – Standard Cranial Reference Array

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

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
    2012-08-14
  • Date de publication de l'événement
    2012-08-14
  • 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_20120814.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: brainlab cranial navigation system – standard cranial reference array the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning cranial navigation system – standard cranial reference array manufactured by brainlab ag. manufacturing tolerances of the arrays influence the actual position of its marker spheres. the differences between the individual arrays are supposed to be very small, not significantly affecting navigation accuracy when the unsterile array is exchanged with the sterile array during surgery. however, according to the manufacturer, there are specific pairs of arrays that might add an inaccuracy of more than 1 mm to the registration result during the exchange due to the combination of their tolerance limits. this effect could potentially cause an inaccurate display of instruments by the navigation system in the region of interest, compared to the actual patient anatomy. if these inaccuracies are not detected by user verification of navigation accuracy as described in the user manual, this could lead to serious injury or ineffective treatment of the patient. customers are advised to remove the affected products from clinical use. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 august 2012.

Device

Cranial Navigation System – Standard Cranial Reference Array
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: BrainLab Cranial Navigation System – Standard Cranial Reference Array
  • Manufacturer
    BrainLab AG

Manufacturer

BrainLab AG