BEUDAMED
    FDA Recall Terminated

    Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications

    Recall: Z-2848-2020 · Initiated July 14, 2020

    Recall

    Recall Number
    Z-2848-2020
    Event Number
    86116
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 14, 2020
    Posted
    August 22, 2020
    Terminated
    July 23, 2021
    Address
    40 Liberty Blvd, Malvern, PA, 19355

    Description

    Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications

    Reason

    Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D80 (below revision 04 installed) of the generator which is part of the main unit (c-arm) and cause permanent loss of imaging functionality.

    Action

    Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice to affected customers via AX013/20/S dated July 14, 2020, The letter states reason for recall, health risk and action to take: We advise urgently to cease the use of the hot plugging feature until the pending hardware update AX014/20/S has been completed. Siemens will correct the hardware error via Update Instruction AX014/20/S in which a Siemens Service Engineer will replace the main control D80. Service organization will contact you shortly to arrange a date to performthis corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Acknowledge Receipt of this Safety Advisory Notice.

    Distribution

    Nationwide

    Quantity

    US: 282 units; OUS: 1363