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:
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