BEUDAMED
    FDA Recall Terminated

    MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1

    Recall: Z-0344-2023 · Initiated November 18, 2022

    Recall

    Recall Number
    Z-0344-2023
    Event Number
    91178
    Firm
    Mobius Imaging, LLC
    FEI Number
    3010151377
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 18, 2022
    Posted
    December 6, 2022
    Terminated
    February 26, 2025
    Address
    2 Shaker Rd, Ste F100, Shirley, MA, 01464-2535

    Description

    MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1

    Reason

    Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with units whose battery monitoring systems were bypassed to charge the batteries; the batteries in these units require replacing.

    Action

    On November 18, 2022, the firm notified affected customers via Urgent Medical Device Correction letters. Customers were informed that a service representative will contact their facility to schedule a time to replace the batteries in the affected devices. The customer does not need to take additional action while waiting for the battery preplacement. If you have any questions or concerns regarding this update, please contact [email protected] or call Stryker Technical Support at 978 386 9619.

    Distribution

    Domestic distribution to consignees in Colorado, Tennessee, and Utah.

    Quantity

    3