FDA Device recall Z-2136-2015
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 softwa…
- FDA Device
- Class II
- terminated
- Published 2015-07-29
On 2015-07-29 the FDA classified a Class II recall of Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 softwa… by Volcano, citing A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2136-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-22 |
| Published | 2015-07-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Volcano |
| Distribution | US |
Product
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature
Reason
A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
Identifiers
| code_info | Model CORE. Part number: 400-0100.02. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2136-2015%22
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