BEUDAMED
    FDA Recall Terminated

    Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A

    Recall: Z-0204-2016 · Initiated November 19, 2014

    Recall

    Recall Number
    Z-0204-2016
    Event Number
    69712
    Firm
    Philips Medical Systems, Inc.
    FEI Number
    1218950
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 19, 2014
    Posted
    November 3, 2015
    Terminated
    August 15, 2016
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A

    Reason

    1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and with no battery installed or the battery installed has a charge level of less than 10%, the Ready for Use (RFU) indicator will not provide the expected low battery indication

    Action

    Philips Healthcare sent an " Urgent Field Safety Notice " dated November 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A hardware upgrade will be provided free of charge for all units affected by this issue. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrade. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: A Philips authorized service provider will service the device and ensure it is operating within specification. Prior to receiving service, you can continue to use your MRx provided that the following steps are followed. These steps will prevent further accelerated degradation of the therapy capacitor, and will eliminate the above described behavior for no/low battery conditions. To correct the problem, set the configuration of the MRx to factory defaults in configuration mode. Please contact your local Philips Service Representative for further questions, or call (978) 687-1501.

    Distribution

    Worldwide Distribution - USA (nationwide), Australia, Austria, Bahrain, Belgium, Brunei Darussalam, Canada, China, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Republic of Korea, Libyan Arab Jamahiriya, Lithuania, Mexico, Namibia, Netherlands, Palestine, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates and United Kingdom.

    Quantity

    1553 units