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.
- Company
- Volcano Corp
- Recall Initiated
- September 23, 2013
- Posted
- July 8, 2015
- Terminated
- July 9, 2015
- Recall Number
- Z-2044-2015
- Quantity
- 227 total units - all models
- Firm Location
- San Diego, CA
Reason for Recall
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.
Distribution
Worldwide Distribution - US Nationwide and the countries of Belgium, United Kingdom, Denmark, Netherlands, Sweden, Iceland, France, Saudi Arabia, Australia, Philippines and Thailand.
Lot / Code Info
Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. All software versions
Root Cause
Nonconforming Material/Component
Action Taken
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.