BEUDAMED
    FDA Recall Open, Classified

    Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6) Azurion 7820/15: 722068, 722226; (7) Azurion 7M12: 722078, 722223; (8) Azurion 7M20 : 722079, 722224

    Recall: Z-1647-2023 · Initiated March 21, 2023

    Recall

    Recall Number
    Z-1647-2023
    Event Number
    92165
    Firm
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands
    FEI Number
    3002807880
    Product Code
    OWB
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 21, 2023
    Posted
    September 30, 2024

    Description

    Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6) Azurion 7820/15: 722068, 722226; (7) Azurion 7M12: 722078, 722223; (8) Azurion 7M20 : 722079, 722224

    Reason

    Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure

    Action

    Philips issued Urgent Medical Device Letter to US consignees via e-mail on March 21, 2023 and certified email on March 29, 2023. Letters outside of the U.S.A. will be distributed through the local Philips Organizations. Letter states reason for recall, health risk and action to take: Keep this Medical Device Correction with the documentation of the system until Philips corrects your system. Circulate this notice to all users of the system so that they are aware of the issue. Return the attached reply form to Philips to confirm that the users of the system have reviewed and understood this Medical Device Correction. US: Please return this signed form via email to: [email protected] or alternatively via regular mail to Philips at 222 Jacobs Street, Cambridge, MA 02141 for the attention of Mr. Roland Telson / 3rd Floor Philips is working on a software release that will correct this issue (reference FCO72200528). In the interim, until this software is available and installed in your affected system(s), Philips will be removing the Log Trace Files from the affected systems to free up disk capacity (reference FCO72200529). Philips will be prioritizing these activities based on the time the affected software release has been installed in the Philips Azurion system. You will be contacted by your local Philips representative to schedule these activities. If you need any further information or support concerning this issue, contact your local Philips representative.

    Distribution

    Nationwide Foreign: Algeria Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Cambodia Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cyprus Czech Republic Denmark Dominican Rep Ecuador Egypt Estonia Finland France French Polynesia Germany Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kosovo Kuwait Latvia Lebanon Lithuania Macao Macedonia Malaysia Mexico Morocco Myanmar Nepal Netherlands New Zealand Nicaragua Nigeria Norway Oman Pakistan Palestine Palestine, State of Panama Peru Philippines Poland Portugal Puerto Rico Qatar Romania Russian Federation Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa South Korea Spain Sri Lanka Sweden Switzerland Taiwan Thailand Tunisia Turkey Turkmenistan Ukraine United Kingdom Utd.Arab.Emir. Uzbekistan Vietnam Yemen

    Quantity

    USA: 1063 R.O.W. 2136