BEUDAMED
    FDA Recall Open, Classified

    Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085

    Recall: Z-1417-2025 · Initiated February 25, 2025

    Recall

    Recall Number
    Z-1417-2025
    Event Number
    96286
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    JEA
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    February 25, 2025
    Posted
    March 21, 2025
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085

    Reason

    There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

    Action

    Baxter issued an UREGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/25/2025 by letter sent via traceable means. The notice explained the issue, hazard involved, and requested the following actions be taken: "Actions to be Taken by Customers 1. Baxter will contact you to install a software upgrade in the impacted surgical table systems. 2. If you received this communication directly from Baxter, acknowledge receipt by following the instructions on the enclosed reply form instruction sheet, even if you have no remaining inventory. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 3. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions. 4. Please forward a copy of this communication to the Medical Director/Office Manager, Director of Pharmacy, Medication Safety Officer, Purchasing Director/Head of Central Supply and any other departments within your institution who use the affected product. 5. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures and check the associated box on the customer portal." "For general questions regarding this communication, please contact Baxter Technical Support at 800-445-3720 (select option 2, then option 7) between 8:00 am and 6:00 pm Eastern Time, Monday through Friday, or email Baxter at [email protected]."

    Distribution

    US Nationwide distribution.

    Quantity

    10 units