Events

Safety Alert for Navigation StealthStation S7 and i7 Systems and Planning Station containing FrameLink Software Version 5.4

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Medtronic Navigation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-07-19
  • Event Date Posted
    2013-07-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130719.html
  • Notes / Alerts
    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.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    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...
  • Model / Serial
  • Product Description
    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
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “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