BEUDAMED
    FDA Recall Open, Classified

    Trexo Device

    Recall: Z-2236-2023 · Initiated May 31, 2023

    Recall

    Recall Number
    Z-2236-2023
    Event Number
    92563
    Firm
    Trexo Robotics Holdings Inc.
    FEI Number
    3015275209
    Product Code
    IKK
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    May 31, 2023
    Posted
    July 25, 2023
    Address
    6705 Millcreek Dr, Unit 3, Mississauga Canada

    Description

    Trexo Device

    Reason

    Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when in use.

    Action

    The firm distributed recall notification to customers by email on 5/31/2023. This notification asks that customers not expose the device to rain or spilled liquids, not store the device outdoors, wear pants to cover exposed skin to minimize the effect of hot surfaces, and if experiencing any electrical interference or difficulty operating another device in the vicinity of a Trexo device move away and and/or turn off the Trexo Device. Affected devices will be subject to a correction which will be carried out by technician; technician appointments will be scheduled once customers reply to the recall notification. Customers with any questions or concerns may contact the firm at [email protected]. Customers are asked to return the provided response form.

    Distribution

    Worldwide distribution - US Nationwide and the countries of the Argentina, Australia, Brazil, Canada, China, Croatia, Czech Republic, England, Germany, India, Kuwait, Mexico, Poland, Qatar, Republic of Cyprus, Serbia, Singapore, Slovakia, Spain, United Arab Emirates, and Yemen.

    Quantity

    357 units