| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00167-1 |
| Product Name/Description |
Vitrea Enterprise Suite: Vitrea, Vitrea fX and VitreaCore (Tool for analysis of diagnostic images)
All versions prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3
ARTG Number: 142791 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
During internal testing, the manufacturer Vital images has found that an error can occur when images are rotated in non-90 degree increments of the transverse/axial plane (rotation around the z-axis), while not being simultaneously rotated around the x-axis and y-axis. This orientation adjustment has been found to occur on rare occasions, such as to straighten tilts in head or neck scans, usually with minimal effect on measurements, but sometimes resulting in differences in length measurements of up to twenty nine percent and in volume measurements of up to fifty percent. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Vital Images recommends that all measurements associated with the issue are verified against results from other technologies. A software patch is under development to correct the issue. |
| Contact Information |
07 5531 7385 - CELEO Pty Ltd |