BEUDAMED
    FDA Enforcement Class II Terminated

    Widefield OCT software feature for the Spectralis HRA+OCT and variants

    Recall: Z-1535-2018 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1535-2018
    Event ID
    79453
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Heidelberg Engineering
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 2, 2018
    Initiation Date
    December 8, 2017
    Classification Date
    April 26, 2018
    Termination Date
    June 4, 2020
    Address
    10 Forge Pkwy, N/A, Franklin, MA, 02038-3137, United States

    Description

    Widefield OCT software feature for the Spectralis HRA+OCT and variants

    Reason

    FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature, and, on November 27, 2017, Heidelberg Engineering submitted a new 510(k) for this feature. FDA has asked Heidelberg Engineering to instruct customers not to use the Widefield OCT software feature on the SPECTRALIS device until 510(k) clearance has been obtained for this software feature.

    Code Info

    The Widefield OCT software feature was made available on the SPECTRALIS Software US versions 6.3 to 6.8a It is only usable with the Widefield Objective Module accessory and a dedicated license.

    Distribution

    Nationally

    Quantity

    382