BEUDAMED
    FDA Enforcement Class II Terminated

    Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine examinations including: Urograms with injection or infusion Retrograde pyelography Cystography and urethrography Micturition cystography Cystoscopy, endopscopy Transurethral resection Percutaneous nephroscopy Urethrorenoscopy Percutaneous nephrolithotomy Serial angiography with image intensifier and DSI Tomography

    Recall: Z-1053-2019 · Reported April 3, 2019

    Enforcement

    Recall Number
    Z-1053-2019
    Event ID
    82313
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips North America, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 3, 2019
    Initiation Date
    February 28, 2019
    Classification Date
    March 23, 2019
    Termination Date
    August 3, 2020
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    Description

    Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine examinations including: Urograms with injection or infusion Retrograde pyelography Cystography and urethrography Micturition cystography Cystoscopy, endopscopy Transurethral resection Percutaneous nephroscopy Urethrorenoscopy Percutaneous nephrolithotomy Serial angiography with image intensifier and DSI Tomography

    Reason

    The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.

    Code Info

    Serial codes 1 2 3 4 5 7 8 11 13 14 15 16 17 18 21 48 59 60 64

    Distribution

    US Nationwide domestic distribution, and worldwide international distribution.

    Quantity

    1969