Every recall we track for Volcano Corporation — 6 in all — plus the complaints and injury reports the public filed about them.
Volcano recalls SyncVision Systems with software version 4.2.x due to potential incorrect iFR/FFR co-registration results, which could lead to inappropriate patient treatment. Affected units have specific serial numbers and software versions.
Philips Volcano FFR software used in specific imaging systems connected to Hemodynamic Systems may cause interoperability issues. Affected units include Volcano s5i, s5ix, and CORE Mobile Imaging Systems with certain part numbers. No remedy is stated in the recall notice.
Volcano recalls PV .035 Digital IVUS Catheters (catalog 81234) due to potential guidewire failure at y-port. Affected units include specific batch numbers. Contact for remedy.
Volcano Corporation recalls PV .035 Digital IVUS Catheters (catalog 88901) due to potential guidewire failure at y-port. Affected units include specific batch numbers for cardiac imaging procedures.
Philips Volcano CORE M2 Vascular System (Part #400-0100.17) with specific serial numbers recalled due to incorrect resistor causing overly bright IVUS images. Affected units may show inaccurate vascular imaging results.
Volcano Corporation 121020083482
