Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19005 |
| Brand Name: | Volcano s5/s5i/CORE/CORE Mobile Systems with FFR option |
| Model: | Volcano s5 and CORE series |
| Affected: | Software versions 3.3, 3.4 (with and without iFR Scout technology) and v3.4 software kits |
| Software version: | |
| Recalling Organisation: | Device Technologies New Zealand 47 Arrenway Drive Albany AUCKLAND 0632 |
| Contact Information: | 09 913 2000 |
| Manufacturer: | Volcano Corporation |
| Issue: | Volcano Corp. has discovered a very specific workflow scenario where the Aortic pressure (Pa) offset used in the FFR/iFR modalities will be lost or reset to 0 mmHg due to a software error. This issue can lead to an inaccurately calculated FFR or iFR value. Should this occur, a clinician may rely on an inaccurate value in diagnosing a patient's condition. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 15/9/2015 |
