Product Wiki · Recalls · U.S. FDA — Device Enforcement

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. — recall Z-2044-2015

U.S. FDA — Device Enforcement · United States · 2013-09-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2044-2015
Date of alert
2013-09-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Volcano Corp
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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