BEUDAMED
    FDA Recall Open, Classified

    The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752; (c) Symbia Pro.specta X7, Model 11364753.

    Recall: Z-2256-2023 · Initiated July 12, 2023

    Recall

    Recall Number
    Z-2256-2023
    Event Number
    92704
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    1000514697
    Product Code
    KPS
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    July 12, 2023
    Posted
    July 28, 2023
    Address
    2501 Barrington Rd, Hoffman Estates, IL, 60192-2061

    Description

    The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752; (c) Symbia Pro.specta X7, Model 11364753.

    Reason

    During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed leading to a reduction in image resolution.

    Action

    The firm issued undated letters flagged Customer Safety Advisory Notice CAN 001-2023 on 7/12/2023 via email, certified mail, or, if necessary, hand delivery. The letter explains the issue, when the malfunction occurs, the potential risks, and how the consignee can help to avoid the potential risk of the issue. The letter informs the consignee that Siemens Healthineers is working to address the issue through a scheduled service visit and the consignee's local service organization will begin contacting the consignees in the 4th quarter of 2023 to schedule this work. In the meantime, the notice is to be placed in the Symbia Pro.specta Operator Manual and disseminated to all operators of the scanner. No response form was enclosed. The recalling firm uses an SAP system for tracking purposes. For the letters that are delivered via email, the consignee verifies receipt through an adobe signature. For the letters delivered via certified mail, there is a return receipt.

    Distribution

    Distribution was made to ID, KS, MA, NH, OH, TX, and VA. There was no government/military distribution. Foreign distribution was made to Argentina, Australia, Austria, Belgium, Canada, Colombia, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Netherlands, Portugal, Singapore, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

    Quantity

    108 systems