| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00722-1 |
| Product Name/Description |
Medtronic Navigation Framelink (used with Medtronic Navigation StealthStation S7 and i7 systems or a Medtronic Planning Station for image guided surgery)
Software version 5.4
Product Number: 9734047
All lot numbers of version 5.4 affected
ARTG Number: 126293 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
19/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has identified that the use of high resolution exams (greater than 256 x 256) under certain use 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, visualisation of the planned trajectory could show the image at the incorrect depth. Further internal investigation of similar or related views discovered that the use of high resolution exams (greater than 256 x 256) under certain use conditions may cause a similar discrepancy between the exam image and the displayed measurement or overlay. The use conditions are;
- Use of FrameLink 5.4 software on an S7, i7 or Planning Station System that has a Rollingstone computer, and
- The FrameLink 5.4 software configuration setting "use FillSliceStackResolution" is set to true, and
- The user loads a high-resolution exam for use during a surgical procedure. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medtronic is requesting users to not use high-resolution examinations (greater than 256 x 256). A software solution will be implemented to permanently correct the issue. |
| Contact Information |
02 9857 9179 - Medtronic Technical Services |