BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated July 10, 2023

    Recall

    Recall Number
    Z-2463-2023
    Event Number
    92713
    Firm
    Stryker Corporation
    FEI Number
    3015967359
    Product Code
    PVZ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    July 10, 2023
    Posted
    August 25, 2023
    Address
    1941 Stryker Way, Portage, MI, 49002-9711

    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

    Action

    Stryker issued Urgent Medical Device Correction Letter addressed to: IT Director, Materials Manager, Risk Manager, OR Director, OR Coordinator sent July 10, 2023 via 2-day Fed'X delivery. Letter states reason for recall, health risk and action to take: 1. Immediately review this software update notification. Advise OR staff, and all other personnel who may use this product, of the information in the notification. 2. Ensure all Stryker surgical tablets using Surgicount+ software is connected to the local facility Wi-Fi so that the software update can be automatically transmitted. Press INSTALL once the update notification appears on the tablet to complete the update. Contact your local sales representative or technical support at 1-800-253-3210 for any assistance or questions. 3. Sign and return the enclosed Business Reply Form to [email protected]. 4. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. We apologize for any inconvenience this action may cause your facility. Please forward a copy of this letter to any other personnel within your facility that you deem appropriate. Please contact Jordan Anderson at (269) 800-1347 or [email protected] with questions or concerns.

    Distribution

    US Nationwide distribution.

    Quantity

    57 units