Recall Z-2044-2015 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Volcano Corp
Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
| Date | Jul 8, 2015 (initiated Sep 23, 2013) |
| Status | Terminated |
| Reason | A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output. |
| Root cause | Nonconforming Material/Component |
| Action | Volcano and Philips sent an Advisory Notice letter dated September 23, 2013 to all impacted customers. The letter identified the affected product, problem and actions to be taken. For question contact your Volcano and Philips representative. |
| Quantity | 227 total units - all models |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Belgium, United Kingdom, Denmark, Netherlands, Sweden, Iceland, France, Saudi Arabia, Australia, Philippines and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123898 | VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM Volcano Corporation, Jan 14, 2013 |