BEUDAMED
    FDA Recall Open, Classified

    epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11

    Recall: Z-0601-2024 · Initiated October 19, 2023

    Recall

    Recall Number
    Z-0601-2024
    Event Number
    93388
    Firm
    Siemens Healthcare Diagnostics Inc
    FEI Number
    3002637618
    Product Code
    CHL
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    October 19, 2023
    Posted
    December 21, 2023
    Address
    2 Edgewater Dr, Norwood, MA, 02062-4637

    Description

    epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11

    Reason

    Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run on the epoc NXS Host and Delete Blood Tests feature is enabled, the results that are generated at the time of testing are correct; however, when this issue occurs, results that are printed, saved and/or transferred to a data manager, may include unselected analytes that are from a previous patient or QC test. The worst possible outcome may result in a failure to diagnose hyperkalemia, due to an erroneous depressed potassium level or inappropriate treatment to hyperglycemia due to erroneous glucose reading.

    Action

    An Urgent Medical Device Correction notification letter dated October 2023 was sent to customers. Actions to be Taken by the Customer Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. To mitigate this issue, follow the instructions below to set Delete Blood Test settings to NEVER and continue using device as normal. To change the device setting: 1. Log in as Administrator 2. Select Settings 3. Select General Settings 4. In the General Settings, scroll to the bottom and select Delete Blood Tests 5. Set Delete Blood Tests to Never. If a Data Manager is in use, the Delete Blood Tests option must be changed on the Data Manager. Do NOT make the change on the epoc Host as the setting will be overwritten on the next synchronization. The Delete Blood Tests option may have a different name depending on the Data Manager in use. Please contact the Data Manager customer service for additional support, if needed. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you are a distributor, please ensure your customers receive this UMDC letter. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. This issue will be corrected with the next NXS software version (4.12.XX) which must be installed by December 12, 2023, when current software version (4.11.11) expires. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.

    Distribution

    US Nationwide. Global Distribution.

    Quantity

    10,183 devices