Events

Alerte De Sécurité sur Navigation StealthStation S7 and i7 Systems and Planning Station containing FrameLink Software Version 5.4

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

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
    2013-07-19
  • Date de publication de l'événement
    2013-07-19
  • 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_20130719.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: medtronic navigation stealthstation s7 and i7 systems and planning station containing framelink software version 5.4 medical device manufacturer, medtronic navigation, inc. issued a medical device safety alert concerning navigation stealthstation s7 and i7 systems and planning station containing framelink software version 5.4. the following part numbers are affected: 9734047 (framelink s7 applications kit) 9734066 (framelink s7 planning station kit) 9733986 (framelink application software) medtronic has identified that the use of high resolution exams (greater than 256 x 256) under certain conditions may cause the look-ahead view labels to show user selected depths (displayed), but the corresponding images are shown at a depth twice the selected distance. under these conditions, visualization of the planned trajectory could show the image at the incorrect depth. medtronic has received three customer reports related to this issue. none of the reports cited any patient injuries or adverse events. according to the manufacturer, the framelink software version 5.4 has been revised to correct the software anomalies mentioned above. until the software upgrade has been installed, users are advised not to use high resolution examinations (greater than 256 x 256). if users are not sure of the exam resolution being used, they should contact the local supplier for assistance. according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 july 2013.

Device

Navigation StealthStation S7 and i7 Systems and Planning Station containing FrameLink Software Ve...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medtronic Navigation StealthStation S7 and i7 Systems and Planning Station containing FrameLink Software Version 5.4
  • Manufacturer
    Medtronic Navigation

Manufacturer

Medtronic Navigation
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH