FDAFDA · Food and drugs·Recall number Z-2043-2015
Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x - 807300-001; CORE MOBILE - 400-0100.01. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
Published July 15, 2015 · Recall initiated: September 23, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Volcano Corp
- Distributor
- Worldwide Distribution - US Nationwide and the countries of Belgium, United Kingdom, Denmark, Netherlands, Sweden, Iceland, France, Saudi Arabia, Australia, Philippines and Thailand.
- Lot
- s5 Part number 804200-002 and 804200-014; s5x Part number 807300-001; CORE MOBILE Part Number 400-0100.01. All software versions
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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