BEUDAMED
    FDA Recall Terminated

    Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224

    Recall: Z-0471-2022 · Initiated November 12, 2021

    Recall

    Recall Number
    Z-0471-2022
    Event Number
    89174
    Firm
    Philips North America Llc
    FEI Number
    3016618143
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 12, 2021
    Terminated
    February 5, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224

    Reason

    (1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available

    Action

    Philips issued Field Safety Notice on 11/12/21 U.S.A, Customer notified via certified mailing from the United States Postal Service (USPS). Letters outside of the U.S.A. will be distributed through the Philips Markets Organization. Letter states reason for recall, health risk and action to take: Start-up problem: If the start-up problem occurs, perform a Cold Restart* of the system. b) Emergency stop recovery problem: If the emergency stop recovery problem occurs, perform a new Warm Restart* of the system. c) Place this Field Safety Notice with the documentation of the system until Philips has installed a software update in your system. d) Circulate this notice to all users of this device so they are aware of the product issues. e) Return the attached reply form to Philips to confirm that the users of the system have reviewed and understood this Field Safety Notice. * The system restart options are described in section 4.2 of the Instructions for Use. 5. Describe the actions planned by Philips IGT Systems to correct these problems: These problems will be resolved by a software update (available in November 2021). You will be contacted by your local Philips representative to schedule the update of your system. If you need any further information, please contact your local Philips representative (reference to FC072200502).

    Distribution

    Worldwide distribution - US Nationwide distribution in the state of WA and the countries of France, Germany, Japan, Poland, United Kingdom.

    Quantity

    10 units (1 US and 9 OUS)