FDAJune 22, 2015device
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 s5x. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evalu...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
What to do
FDA enforcement status: Terminated
Brands named
volcano
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAVolcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.2025-06-13
- FDAPhilips OmniWire Pressure guide wire REF 89185J PN 3000002528912022-05-16
- FDAVolcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 27972022-05-13
- FDAVolcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 27972022-05-13
- FDAMM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems2022-02-03
- FDAIntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 3000020181022022-01-24
- FDASyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x2022-01-19
- FDAPhilips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1) Volcano Imaging System s5i, Part #807400001; (2) s5ix Imaging System with s5iz PC Workstation Refurbished, Part#807400001 R and 807401200; (3) s5i ...2018-11-07
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