Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 13556 |
| Brand Name: | Volcano s5/s5i Imaging Systems |
| Model: | Models s5 & s5i |
| Affected: | Versions 3.2.1 / 3.2.2 |
| Software version: | |
| Recalling Organisation: | Device Technologies New Zealand 47 Arrenway Drive Albany AUCKLAND 0632 |
| Contact Information: | 09 913 2000 |
| Manufacturer: | Volcano Corporation |
| Issue: | Under very specific and remote conditions two software display errors may occur on the 3.2x Intravascylar Ultrasound (IVUS) software when used with Digital IVUS Catheter and the Rotational revolution 45 MHz Catheter. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 27/9/2012 |
