BEUDAMED
    FDA Recall Terminated

    Robotic hand accessory to InMotion Arm, rehabilitation robot.

    Recall: Z-0199-2016 · Initiated May 5, 2012

    Recall

    Recall Number
    Z-0199-2016
    Event Number
    72326
    Firm
    Interactive Motion Technologies, Inc.
    FEI Number
    3002758968
    Product Code
    IKK
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    May 5, 2012
    Posted
    November 2, 2015
    Terminated
    July 13, 2017
    Address
    80 Coolidge Hill Rd, Watertown, MA, 02472-5003

    Description

    Robotic hand accessory to InMotion Arm, rehabilitation robot.

    Reason

    Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover and expose a potential pinch hazard.

    Action

    Interactive Motion Technology ( IMT) sent an Important Patient Safety Information letter dated March 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Summary of Actions to be taken For Hand Robot Cover B, firm recommends continued vigilance for both Adult and Pediatric Patients while in contact with this group of devices. For Hand Robot Covers A or C, at clinician discretion based on expected patient population, firm recommends continued use when appropriate of the IMT supplied Hypertonia Spring Assembly, or if not appropriate, insertion of the IMT Zero Force Spring Assembly. IMT will make this kit available for each Hand Robot upon request, or insert the Assembly when the Hand Robot is shipped to IMT using the special shipping container. If you have any questions, please contact your local IMT Representative or IMT Technical Services at [email protected].

    Distribution

    Worldwide Distribution - US Distribution to the states of : Texas and Tennessee., and to the countries of : China, Brazil, Hong Kong, Austria and South Korea.

    Quantity

    8