BEUDAMED
    FDA Enforcement Class II Ongoing

    UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of temporary to short-term duration, especially in ophthalmology Art.no. / REF no.: 15000004 Art.no. / REF no.: 15000006

    Recall: Z-2212-2023 · Reported July 26, 2023

    Enforcement

    Recall Number
    Z-2212-2023
    Event ID
    92534
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    UFSK - International OSYS Gmbh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 26, 2023
    Initiation Date
    May 31, 2023
    Classification Date
    July 20, 2023
    Address
    Kirchhoffstr. 1, N/A, Ratisbon, N/A, N/A, Germany

    Description

    UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of temporary to short-term duration, especially in ophthalmology Art.no. / REF no.: 15000004 Art.no. / REF no.: 15000006

    Reason

    Service life of the electrical seat part drive of the treatment chair may be shortened unexpectedly after several years of use due to a potential wear-related reduction in the self-locking of the drive and may remain undetected. A worsened self-locking of the seat drive can lead to overriding the drive s end position when positioning the patient with the seat part in an inclined position

    Code Info

    Art.no. / REF no.: 15000004 Serial number range: 2000- 2999 Art.no. / REF no.: 15000006 Serial number range: 3000-4506

    Distribution

    Nationwide

    Quantity

    239 chairs US