BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0957-2023 · Initiated December 7, 2022

    Recall

    Recall Number
    Z-0957-2023
    Event Number
    91258
    Firm
    Mobius Imaging, LLC
    FEI Number
    3010151377
    Product Code
    JAK
    Status
    Open, Classified
    Root Cause
    Use error
    Initiated
    December 7, 2022
    Posted
    January 17, 2023
    Address
    2 Shaker Rd, Ste F100, Shirley, MA, 01464-2535

    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.

    Action

    On December 7, 2022, the firm notified customers via Urgent Medical Device Correction letters. Customers were informed that the firm would add additional warning labels to the Airo to increase visibility of instructions for users to consider when transporting an Airo TruCT unit in reverse. A service representative will contact your facility once labels are available (anticipated February 2023) to schedule a time to affix the labeling to your Airo TruCT unit. In the interim, please ensure all Airo TruCT users and other relevant personnel in your facilities are informed of this issue. If the devices have been distributed to other organizations, inform Stryker so that they may inform personnel at the new locations appropriately. If you have any questions or concerns regarding this notification, please contact [email protected] or call Stryker Technical Support at 978 386 9619.

    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