BEUDAMED
    FDA Enforcement Class II Ongoing

    MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.

    Recall: Z-0957-2023 · Reported January 25, 2023

    Enforcement

    Recall Number
    Z-0957-2023
    Event ID
    91258
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Mobius Imaging, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 25, 2023
    Initiation Date
    December 7, 2022
    Classification Date
    January 17, 2023
    Address
    2 Shaker Rd Ste F100, N/A, Shirley, MA, 01464-2535, United States

    Description

    MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.

    Reason

    Stryker received one report of an injury to an untrained user that occurred while the untrained user was moving an Airo TruCT unit in reverse. The firm will increase visibility of instructions for users to consider when transporting the unit in reverse by providing labels to be affixed onto the AIRO.

    Code Info

    UDI-DI: 00869346000200 ALL Serial numbers

    Distribution

    Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Chinese Taipei, Denmark, Egypt, France, Germany, India, Italy, Japan, Kazakhstan, Korea, Republic of Kuwait, Lithuania, Malaysia, Mexico, Morocco, Nepal, Netherlands, Norway, Pakistan, Poland, Russian Federation, Saudi Arabia, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdom, Viet Nam.

    Quantity

    303