BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported October 11, 2023

    Enforcement

    Recall Number
    Z-2650-2023
    Event ID
    92945
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Icecure Medical Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 11, 2023
    Initiation Date
    September 16, 2019
    Classification Date
    September 29, 2023
    Address
    7, Ha-Eshel, N/A, Caesarea, N/A, N/A, Israel

    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)

    Code Info

    UDI: (1)FAS3000000, UDI: 07290015487160 (2)FAS3000000-2, UDI: 07290015487290 All User Manual Revisions up to Rev.D.

    Distribution

    US Nationwide distribution.

    Quantity

    16 units