BEUDAMED
    FDA Enforcement Class II Terminated

    Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance to patient motion during rehabilitation therapy. The Primus that includes the optional Chop / Lift Bar.

    Recall: Z-1986-2015 · Reported July 15, 2015

    Enforcement

    Recall Number
    Z-1986-2015
    Event ID
    71443
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BTE Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 15, 2015
    Initiation Date
    April 9, 2015
    Classification Date
    July 6, 2015
    Termination Date
    May 10, 2016
    Address
    7455 New Ridge Rd Ste L, N/A, Hanover, MD, 21076-3143, United States

    Description

    Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance to patient motion during rehabilitation therapy. The Primus that includes the optional Chop / Lift Bar.

    Reason

    On the Primus that includes the optional Chop / Lift Bar, there is a remote possibility that the Chop / Lift Bar could get accidently detached from the snap hook in specific use scenarios when the bar is rotated and twisted around the snap hook. The snap hook could open, resulting in possible injury to the user due to a fall.

    Code Info

    Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30)

    Distribution

    Worldwide Distribution - Nationwide Distribution and to the countries of : Austria, Belgium, Canada, France, Germany, Greece, Hong Kong, Italy, India, Japan, South Korea, Mexico, P.R. China, Poland, Republic of South Africa, Romania, Saudi Arabia, Singapore, Spain, Switzerland, Thailand, and United Kingdom.

    Quantity

    510 Devices