BEUDAMED
    FDA Recall Terminated

    Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Angiography systems developed for single and biplane diagnostic imaging

    Recall: Z-2404-2021 · Initiated June 30, 2021

    Recall

    Recall Number
    Z-2404-2021
    Event Number
    88412
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 30, 2021
    Terminated
    February 10, 2023
    Address
    40 Liberty Blvd, Malvern, PA, 19355

    Description

    Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Angiography systems developed for single and biplane diagnostic imaging

    Reason

    Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart, and result in delay of clinical treatment

    Action

    Siemens Medical Solutions USA, Inc. issued a Customer Safety Advisory Notice to affected customers via AX045/21/S dated 6/30/21. Letter states reason for recall, health risk and action to take: If the BYPASS/ BYPASS FLUORO message does not disappear after approximately four minutes, an additional restart of the Artis system is necessary. Please follow the standard emergency procedures you have in place in the event of system failures. It is recommended to consider reinforcing these emergency procedures until the update has been completed. Siemens will provide a software update for all affected systems via Update Instruction AX044/21/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein.

    Distribution

    US Nationwide distribution in the states of AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, ND, NE, NH, NJ, NV, NY, OH, PA, TN, TX, UT, VA, WA, WI.

    Quantity

    70 US (172 WW)