Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22333 |
| Brand Name: | Volcano - Imaging Systems |
| Model: | |
| Affected: | Configuration issue that affects some s5i, CORE and CORE Mobile systems with software version v3.5 |
| Software version: | |
| Recalling Organisation: | Device Technologies New Zealand 47 Arrenway Drive Albany AUCKLAND 0632 |
| Contact Information: | 09 913 2000 |
| Manufacturer: | Volcano Corporation, Volcarica SRL |
| Issue: | The Microsoft Windows security settings on a small number of Impacted Systems were incorrectly configured during the manufacturing process. This misconfiguration can lead to a Windows Security Alert dialog being displayed when the system is switched from IVUS to the FFR/iFR mode. If the user responds to the dialog by selecting 'Allow Access',the device's network firewall settings will be modified, opening its network ports to potential unexpected communication from the hospital network to which the device may be connected. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 30/11/2017 |
