BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated September 9, 2025

    Recall

    Recall Number
    Z-2673-2025
    Event Number
    97509
    Firm
    MedicalCommunications GmbH Max-Jarecki-Str. 8 Heidelberg Germany
    FEI Number
    3003995303
    Product Code
    NFJ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    September 9, 2025
    Posted
    September 30, 2025

    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.

    Action

    Ashvins notified consignees on about 09/09/2025 via emailed letter. Consignees were instructed to cease using the freeform measurement function in the MMV until the software update has been performed, which is now available. Consignees were instructed to perform the update as soon as possible, complete the digital Field Safety Notice Acknowledgement and Receipt Form, and maintain a copy of the letter and the user manual with the device until the software update is complete.

    Distribution

    US Nationwide distribution.

    Quantity

    474 units