BEUDAMED
    FDA Recall Terminated

    BHM Medical Infrared (IR) Hand Control System, an optional wireless control component of the Arjo Maxi Sky 600 and BHM V4 Ceiling Patient Lifts; the hand control system is composed of two components, part 700.13640.33 - IR hand control, and part 492.00038 - IR receiver board

    Recall: Z-1233-2008 · Initiated February 20, 2008

    Recall

    Recall Number
    Z-1233-2008
    Event Number
    46800
    Firm
    Arjo, Inc.
    FEI Number
    1419652
    Product Code
    FNG
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 20, 2008
    Posted
    July 18, 2008
    Terminated
    September 11, 2010
    Address
    50 Gary Ave, Ste A, Roselle, IL, 60172-1684

    Description

    BHM Medical Infrared (IR) Hand Control System, an optional wireless control component of the Arjo Maxi Sky 600 and BHM V4 Ceiling Patient Lifts; the hand control system is composed of two components, part 700.13640.33 - IR hand control, and part 492.00038 - IR receiver board

    Reason

    The ceiling lift may not stop lateral movement after releasing the left (or right) action button on a ceiling lift equipped with an infrared hand control.

    Action

    Arjo sent Urgent Device Field Correction Notification letters dated 2/15/08 on the BHM Medical letterhead to the end user accounts who received the affected IR remotes, advising them of the potential for the remote to become difficult to operate or to create uncontrolled movement of the ceiling lift. The accounts were instructed to remove the IR remote from service until the field correction is issued by BHM Medical. Instructions for removal of the IR equipment were provided in the Safety Advisory Notice included with the letter. The accounts were requested to complete and return the enclosed customer response form, acknowledging the receipt and understanding of the letter, and indicating the number of units requiring correction.

    Distribution

    Nationwide Distribution.

    Quantity

    25 units