BEUDAMED
    FDA Recall Terminated

    VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure.

    Recall: Z-1145-2020 · Initiated December 23, 2019

    Recall

    Recall Number
    Z-1145-2020
    Event Number
    84708
    Firm
    Philips North America, LLC
    FEI Number
    1218950
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 23, 2019
    Posted
    February 10, 2020
    Terminated
    November 17, 2022
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure.

    Reason

    Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction.

    Action

    On 12/23/2019, the firm sent medical device correction letters to affected customers via certified mail. The firm will be contacting customers with affected systems. The firm will be implementing software updates in all affected systems to correct the issue which was made available by the end of December 2019. The user was asked to do the following: -Please suspend the use of Digital Subtraction Angiography images for the verification of the registration during the Live Guidance step. -Please ensure that all staff working with the VesselNavigator application are informed of the recall. If you need further information or support concerning this issue, please contact your local Philips representative or call Technical Support Line at 1-800-722-9377.

    Distribution

    Worldwide Distribution. US nationwide, Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Latvia, Libya, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Uruguay.

    Quantity

    443