BEUDAMED
    FDA Recall Open, Classified

    ProxiDiagnost N90 R.1.0

    Recall: Z-1587-2023 · Initiated March 3, 2023

    Recall

    Recall Number
    Z-1587-2023
    Event Number
    92333
    Firm
    Philips North America
    FEI Number
    3006648320
    Product Code
    JAA
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    March 3, 2023
    Posted
    May 15, 2023
    Address
    222 Jacobs St, Cambridge, MA, 02141-2296

    Description

    ProxiDiagnost N90 R.1.0

    Reason

    Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).

    Action

    Philips sent an Electronic Product Radiation Correction letter dated March 3, 2023, to affected customers. The letter stated a Philips representative will contact affected customers to schedule a time for a Field Service Engineer (FSE) to visit your site to inspect your system and apply the label if necessary. Philips will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan approved by the Secretary of Health and Human Services. Customers were asked to complete and return the attached acknowledgement form to Philips DXR promptly upon receipt and no later than 30 days from receipt via email to: [email protected]. If you need any further information or support concerning this issue, please contact your local Philips Customer Care Solutions center: 1-800-722-9377 (Reference FCO70600112 for ProxiDiagnost N90 R.1.0 and FCO70900060 for CombiDiagnost R90 R.1.0 and R1.1).

    Distribution

    US Nationwide

    Quantity

    25 systems in total