BEUDAMED
    FDA Recall Open, Classified

    Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system

    Recall: Z-1477-2023 · Initiated October 21, 2022

    Recall

    Recall Number
    Z-1477-2023
    Event Number
    91979
    Firm
    Philips North America Llc
    FEI Number
    3016618143
    Product Code
    OWB
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    October 21, 2022
    Posted
    April 28, 2023
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system

    Reason

    Potential table stop due to a broken tabletop cable: On the ProxiDiagnost N90 table there is a cable located under the tabletop that is covered by a plastic sleeve which can crack and damage the cable. If the tabletop cable breaks, the user may not be able to initiate table tilting movements or braking

    Action

    Philips issued a revised customer letter on 3/10/23 via U.S. mail -URGENT Medical Device Correction Notification Update CombiDiagnost R90 and ProxiDiagnost N90 Component damage due to short circuit & table stop due to broken tabletop cable. Customers received previous customer communications : 21 Oct 2021 for ProxiDiagnost N90 1.0 (706100); 17 Nov 2022 for ProxiDiagnost N90 1.1 (706110). Circulate this notice to all users of the device, attach the notice as an addendum to the IFU (User Manual). If a user observes fire in the M-cabinet, sees or smells smoke, or hears a popping noise coming from the M-cabinet, immediately remove power to the room, remove the patient, stop using the system for further examinations. Follow local fire regulations (e.g. evacuation, inform firefighters). Contact Customer Care Solutions Center (1-800-722-9377), reference FCO70900054 (CombiDiagnost R90), FCO70600105 (ProxiDiagnost N90 1.0), or FCO70600108 (ProxiDiagnost N90 1.1) to arrange for a Philips Field Service Engineer to visit your site. (FSE) will visit impacted customer sites to update the system with a hardware component to prevent the issue from occurring. If the table is not tilting or braking as expected: Bring the table back to 0degree position using the Tilting Switch, remove the patient from table, stop using the system for further examinations. Contact Customer Care Solutions Center (1-800-722-9377), reference FCO70600105 (ProxiDiagnost N90 1.0) or FCO70600108 (ProxiDiagnost N90 1.1) to arrange for a Philips Field Service Engineer to visit your site to inspect and fix the cable.

    Distribution

    Worldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Chile, China, Germany, India, Italy, Malaysia, Netherlands, Panama, Spain, Thailand.

    Quantity

    Total Quantity: 234 units. US 195units. R.O.W 39 units