BEUDAMED
    FDA Enforcement Class II Terminated

    Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.

    Recall: Z-1597-2013 · Reported July 3, 2013

    Enforcement

    Recall Number
    Z-1597-2013
    Event ID
    65361
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RF Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2013
    Initiation Date
    May 17, 2013
    Classification Date
    June 26, 2013
    Termination Date
    December 3, 2013
    Address
    3125 N 126th St, Brookfield, WI, 53005-3115, United States

    Description

    Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.

    Reason

    RF Technologies, Inc. has initiated a recall involving CA520 Code Alert Integrated Care Management Advanced 4-Way Care Solution . Due to a firmware error, the alarm may not be transmitted to the system server immediately.

    Code Info

    all codes

    Distribution

    Nationwide Distribution in US including the states of AK, AZ, CA, GA, IA, KY, MT, NE, NJ, ND, and WI.

    Quantity

    167