The Recall Desk

FDA (Devices) recall action 71404

Volcano Corp recalled 3 products on 2015-07-15

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2015-07-15
Critical
0
Units
681

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • ModerateFDA (Devices)··2015-07-15

    Volcano Intravascular Ultrasound System Recalled for Interoperability Limitation

    Volcano Corp is recalling 227 Intravascular Ultrasound Imaging and Pressure Systems due to a limitation in interoperability with the Philips Xper Flex Cardia system that may impact Fraction Flow Reserve calculations.

    Product
    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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-07-15

    Volcano Intravascular Ultrasound System Recalled for Interoperability Limitation

    Volcano Corp is recalling 227 intravascular ultrasound systems due to a limitation that may affect Fraction Flow Reserve calculations when connected to specific Philips monitors.

    Product
    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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-07-15

    Volcano ComboMap Intravascular System Recalled for Interoperability Limitation

    Volcano Corp is recalling 227 ComboMap Intravascular Flow and Pressure Systems due to a limitation in interoperability with the Philips Xper Flex Cardia Physiomonitoring System.

    Product
    ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map - 802745-001. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
    Category
    Distribution
    0 states