FDAApril 25, 2016device
Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels o...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected data from the hospital network and be forced to reboot
What to do
FDA enforcement status: Terminated
Brands named
volcano
UPCs
10195163100105207007001101950286001052071310010520604200111019505470011019501810010520636300110195027700110195129800105207035001101950590001
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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