BEUDAMED
    FDA Enforcement Class II 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 · Reported December 7, 2022

    Enforcement

    Recall Number
    Z-0344-2023
    Event ID
    91178
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mobius Imaging, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 7, 2022
    Initiation Date
    November 18, 2022
    Classification Date
    November 30, 2022
    Termination Date
    February 26, 2025
    Address
    2 Shaker Rd Ste F100, Shirley, MA, 01464-2535, United States

    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.

    Code Info

    UDI-DI 00869346000200 Serial Numbers AIRO-0124, AIRO-0145, AIRO-0288

    Distribution

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

    Quantity

    3