FDANovember 3, 2017device
Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07; CORE Mobile Imaging System Refurbished REF 400-0100.07-R; CORE Mobile Imaging System (100V) REF...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during use, and the users response to the dialog may adversely affect the subsequent operation of the device.
What to do
FDA enforcement status: Terminated
Brands named
volcano
UPCs
121020092284103020086507121070065001103070097001103070103001103020087167121070003001103020092291121020089611103020086243103020096244103070057001
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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