BEUDAMED
    FDA Recall Terminated

    Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.

    Recall: Z-0004-2016 · Initiated July 23, 2015

    Recall

    Recall Number
    Z-0004-2016
    Event Number
    71858
    Firm
    Lifeline Systems, Incorporated
    FEI Number
    1000086682
    Product Code
    ILQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 23, 2015
    Posted
    October 1, 2015
    Terminated
    November 10, 2020
    Address
    111 Lawrence St, Framingham, MA, 01702-8156

    Description

    Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.

    Reason

    Irregular battery disconnection resulted in issues with Mobile Health Button (MHB) Charging.

    Action

    Customers were also notified of the recall via an Urgent: Medical Device Recall sent, by US Mail, between 8/19/2015 and 8/20/2015. The letter described the reason for the recall and how to recognize the device failure. The customer is asked to do the following: 1. Review and confirm the attached list of affected units for your program. Contact the affected subscribers listed and notify them that a service visit will be scheduled so that their units can be replaced within the next few weeks. 2. If any subscribers report any issues with their MHB, contact Philips for an expedited unit replacement and instruct them to discontinue use. 3. Philips Customer Care will follow-up with customers via telephone to ensure that they have received and understood the notification. During this follow-up call, we will also confirm arrangements for unit replacements.

    Distribution

    Nationwide Distribution -- AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, MA, MD, MI, MN, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TX, UT, VA, VT, WA, and WI.

    Quantity

    8,616 devices