BEUDAMED
    FDA Recall Open, Classified

    Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200

    Recall: Z-0195-2024 · Initiated September 12, 2023

    Recall

    Recall Number
    Z-0195-2024
    Event Number
    93127
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    September 12, 2023
    Posted
    October 27, 2023
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200

    Reason

    Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure

    Action

    Siemens Medical Solutions USA issued Urgent Medical Device Correction Letter (AX035/23/S).Letter states reason for recall, health risk and action to take. Siemens will correct the software error via Update Instruction AX036/23/S. With software version VA30K, the user interface of Cios VA30 systems will be changed to consider the current standards DIN 6862-3 and IEC 60601-2-54. 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 Customer Safety Advisory Notice. Please respond within 14 days of receiving this notification. If you have received this notification by email via Adobe GigaSign, kindly sign with your digital signature to acknowledge that you have read and understand the content provided. If you have received this customer notification by delivery by the US Postal Service or by FedEx, please send an email to [email protected] acknowledging that you have read and understand the content provided. Please ensure that all users of the affected products within your organization and others who may need to be informed will receive the relevant safety information provided within this notice and will comply with the recommendations therein.

    Distribution

    Nationwide

    Quantity

    237 units