Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16007 |
| Brand Name: | Vital Images VitreaCore Software |
| Model: | |
| Affected: | |
| Software version: | Versions 6.0 to 6.5 inclusive, including all upgrades (except 6.3.1, 6.4.4 and 6.4.5) |
| 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: | Risk of patient misdiagnosis or inappropriate treatment due to incorrect image orientation marking. This may occur when loading a study into the 3D viewer in VitreaCore, taking a 16-bit secondary capture snapshot of the study and loading this snapshot in a DICOM viewer. Vital Images has provided advice on how to confirm that snapshots are correctly marked. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 21/1/2014 |
