BEUDAMED
    FDA Enforcement Class II Ongoing

    Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System)

    Recall: Z-2673-2025 · Reported October 8, 2025

    Enforcement

    Recall Number
    Z-2673-2025
    Event ID
    97509
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MedicalCommunications GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 8, 2025
    Initiation Date
    September 9, 2025
    Classification Date
    September 30, 2025
    Address
    Max-Jarecki-Str. 8, N/A, Heidelberg, N/A, N/A, Germany

    Description

    Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System)

    Reason

    Potential that the measured value may be smaller than the actual area.

    Code Info

    Model Name: Ashvins variant HEYEX 2 / HEYEX PACS. UDI-DI: 4260648620046. Software Version: 2.6.0 (Build 2088) to 2.6.8 (Build 2220).

    Distribution

    US Nationwide distribution.

    Quantity

    474 units