BEUDAMED
    FDA Recall Open, Classified

    CombiDiagnost R90 1.1 (709031)

    Recall: Z-1088-2024 · Initiated February 11, 2022

    Recall

    Recall Number
    Z-1088-2024
    Event Number
    93819
    Firm
    PHILIPS MEDICAL SYSTEMS
    FEI Number
    3017726341
    Product Code
    JAA
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    February 11, 2022
    Posted
    February 14, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    CombiDiagnost R90 1.1 (709031)

    Reason

    While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.

    Action

    An Important Product Notice (2021-PD-DXR-034) dated February 15, 2022 was issued via Certified Mail. Philips Field Service Engineers will contact customers to schedule an onsite visit to install update software correcting the issue. Customers are asked to follow the provided instructions to ensure there are no pending images before an exam circulate the notice to all users and to complete and return the response form and circulate the notice to all users of the device for awareness. Contact Philips Customer Care Solutions Center 1-800-722-9377 with questions.

    Distribution

    US Nationwide distribution in the states of CA, FL, GA, IL, IN, KS, MD, ME, MI, MN, NC, NJ, NY, TX, VA, WA.

    Quantity

    130 units