BEUDAMED
    FDA Enforcement Class II Ongoing

    SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Product Code: 0694-002-090;

    Recall: Z-2463-2023 · Reported September 6, 2023

    Enforcement

    Recall Number
    Z-2463-2023
    Event ID
    92713
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 6, 2023
    Initiation Date
    July 10, 2023
    Classification Date
    August 25, 2023
    Address
    1941 Stryker Way, N/A, Portage, MI, 49002-9711, United States

    Description

    SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Product Code: 0694-002-090;

    Reason

    Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type

    Code Info

    GTIN 07613327543094 Software Version: 2.1.8 & 2.20

    Distribution

    US Nationwide distribution.

    Quantity

    57 units