FDA Device recall Z-2131-2015
Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 s…
- 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 with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 s… 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-2131-2015 |
| 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 with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5. 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 s5. Part numbers: 804200-002 and 804200-014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Volcano
- Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
FDA Device · Class II · 2026-10-07 · Volcano - Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P
FDA Device · Class II · 2025-08-06 · Volcano - Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
FDA Device · Class III · 2022-07-06 · Volcano - Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
FDA Device · Class III · 2022-07-06 · Volcano - Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
FDA Device · Class II · 2022-06-22 · Volcano
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2131-2015%22
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