BEUDAMED
    FDA Recall Terminated

    Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 722027, 722028.

    Recall: Z-0416-2022 · Initiated November 19, 2021

    Recall

    Recall Number
    Z-0416-2022
    Event Number
    89203
    Firm
    Philips North America Llc
    FEI Number
    3016618143
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 19, 2021
    Terminated
    February 7, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 722027, 722028.

    Reason

    Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the Mounting Ceiling Suspension structure and fall down, may lead to patient, user or service engineer harm that may require medical intervention.

    Action

    Philips issued Medical Device Correction letter to US consignees on 19-Nov-2021. Letters outside of the U.S.A. will be distributed through the Philips Markets Organization. Letter states reason for recall, health risk and action to take: Move the MCS with a 7th or 8th monitor only before or after a procedure. " Do not position the MCS above the patient/sterile field during the procedure. " Place this Field Safety Notice with the system documentation until your system has been fixed. " Circulate this notice to all users of this device so they are aware of the product issues. " Return the attached reply form to Philips to confirm that the users of the system have reviewed and understood this Field Safety Notice. A Philips representative will secure the set of screws of all affected systems. You will be contacted by your local Philips representative to schedule the service. If you need any further information, please contact your local Philips representative (reference to FC072200488).

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of DC, GA, MA, TX, VA and the countries of Dominican Republic, INDIA, Japan, Poland, Spain, Taiwan.

    Quantity

    USA: 5 systems R.O.W.: 15 systems