BEUDAMED
    FDA Recall 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 · Initiated May 17, 2013

    Recall

    Recall Number
    Z-1597-2013
    Event Number
    65361
    Firm
    RF Technologies, Inc.
    FEI Number
    3002286578
    Product Code
    KMI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 17, 2013
    Posted
    June 26, 2013
    Terminated
    December 3, 2013
    Address
    3125 N 126th St, Brookfield, WI, 53005-3115

    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.

    Action

    Consignees were sent on 5/17/2013 a "Medical Device Recall" letter dated 3 May 2013. The letter described the problem and the product involved in the recall. The letter advised consignees to discontinue use of the device and return to RF Technologies.

    Distribution

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

    Quantity

    167