BEUDAMED
    FDA Recall 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 · Initiated February 28, 2019

    Recall

    Recall Number
    Z-1053-2019
    Event Number
    82313
    Firm
    Philips North America, LLC
    FEI Number
    1218950
    Product Code
    IXR
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    February 28, 2019
    Terminated
    August 3, 2020
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    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.

    Action

    On February 28, 2019, the firm notified customers via an Urgent Field Safety Notice letter. The letter informed customers that the affected systems would be inspected for missing locking plates. Customers were asked to place a copy of the Field Safety Notice with the documentation of the system until the system has been inspected by Philips. Philips will inspect all potentially affected systems free of charge. If a locking plate is found missing, Philips will secure the system until a locking plate is installed so that use of the system can continue. You will be contacted by your local Philips representative to schedule the inspection. Philip's action will start effective from March 2019. If you need further information or support concerning this issue, please contact your local Philips representative.

    Distribution

    US Nationwide domestic distribution, and worldwide international distribution.

    Quantity

    1969