BEUDAMED
    FDA Recall Open, Classified

    IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC)

    Recall: Z-2650-2023 · Initiated September 16, 2019

    Recall

    Recall Number
    Z-2650-2023
    Event Number
    92945
    Firm
    Icecure Medical Ltd 7, Ha-Eshel Caesarea Israel
    FEI Number
    3008797959
    Product Code
    GEH
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    September 16, 2019
    Posted
    September 29, 2023

    Description

    IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC)

    Reason

    Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)

    Action

    IceCure notified users on Sep.16th,2019 via email. IceCure Medical has updated the User Manual DSR3200000 Rev. E to include safety guidelines in case of any mechanical damage (e.g. bent cryoprobe) the cryoprobe. Letter states reason for recall, health risk and action to take: The user manual can be found at IceCure Medical website or If you would like to acquire our paper form user manual book, please contact us directly and one will be sent to you within 7 working days. We can be reached at +1-646-844-3066 or via email at [email protected]

    Distribution

    US Nationwide distribution.

    Quantity

    16 units