Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 14241 |
| Brand Name: | Vital Images Vitrea Enterprise Suite, VitreaAdvanced, VitreaCore and Vitrea fX |
| Model: | |
| Affected: | prior to version 6.3.3 except 6.1.6, 6.2.3 and 6.3 |
| Software version: | |
| Recalling Organisation: | Canon Medical Systems ANZ Pty Limited Akoranga Business Park 28 The Warehouse Way NorthCote AUCKLAND 0627 |
| Contact Information: | |
| Manufacturer: | Vital Images Inc |
| Issue: | Manufacturer has found an error regarding measurement. This error occurs when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/xial plane (rotation around the z-axis), while not being simultaenously rotated around the x-axis and y-axis. Manufacturer has found that this orientation adjustement to occur on rare occasions, such as to straighten tilts in head or neck scans, sually with minimal efect on measurements, but sometimes resulting in differences in mength measurement of up to 29% and in volume measurements of up to 50%. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/2/2013 |
