Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24152 |
| Brand Name: | Volcano - Imaging Systems |
| Model: | Volcano s5i, CORE and CORE MOBILE systems |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Device Technologies New Zealand 47 Arrenway Drive Albany AUCKLAND 0632 |
| Contact Information: | 09 913 2000 |
| Manufacturer: | Volcano Corporation |
| Issue: | The version 2.5 FFR/iFR software is designed to calibrate the aortic output of the Hemodynamic Monitoring system (HMS). If the HMS adheres to commonly used pressure calibration values, then the interoperability issue will not have any impact. However, if the system does not adhere to commonly used values , the Volcano Pa(Ao) and the HMS AO may be misaligned by up to +/- 5 mm Hg. This discrepancy may lead to confusion |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 7/2/2019 |
