BEUDAMED
    FDA Enforcement Class II Terminated

    SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.

    Recall: Z-2437-2019 · Reported September 11, 2019

    Enforcement

    Recall Number
    Z-2437-2019
    Event ID
    83568
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Heidelberg Engineering GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 11, 2019
    Initiation Date
    July 3, 2019
    Classification Date
    August 30, 2019
    Termination Date
    November 2, 2020
    Address
    Tiergartenstr. 15, N/A, Heidelberg, N/A, N/A, Germany

    Description

    SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.

    Reason

    Error in the default configuration which could lead to the incorrect display of patient master data.

    Code Info

    All software versions with HEYEX2 image management system Identification: TFID-3439

    Distribution

    US nationwide distribution

    Quantity

    29