BEUDAMED
    FDA Enforcement Class II Terminated

    HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.

    Recall: Z-0603-2019 · Reported December 19, 2018

    Enforcement

    Recall Number
    Z-0603-2019
    Event ID
    81443
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips North America LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 19, 2018
    Initiation Date
    November 23, 2018
    Classification Date
    December 13, 2018
    Termination Date
    September 29, 2020
    Address
    22100 Bothell Everett Hwy, N/A, Bothell, WA, 98021-8431, United States

    Description

    HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.

    Reason

    Affected lithium-ion batteries may contain a defective component (Thermal Cut-off or TCO). Should the component fail, the battery will no longer charge or deliver power to the Monitor/Defibrillator, which may prevent operation of the device if it is not connected to AC or DC power. Should a second, unaffected battery be present in the Monitor/Defibrillator, the battery failure may go unnoticed.

    Code Info

    UDI: (01)00884838002791; Serial Numbers: 17362-0001-P through 18057-0266-P

    Distribution

    U.S.: AZ, WA, PA, UT, NY, CO, MD, AR, TX, MO, MI, FL, VA, MA, GA, TN, NV, OH, CA, NH, KY, KS, OR, WI, NC, IL, LA, NJ, WV, AL, WY, MS Foreign (OUS): United Kingdom, Korea Rep, Singapore, Australia, Taiwan, Sri Lanka, Brazil, France, Switzerland, Germany, Austria, Spain, Italy, Trinidad and Tobago, Estonia, Belgium, Portugal, Korea, Republic of, Argentina, India, Puerto Rico, Qatar, Netherlands, Mexico, South Africa, Ireland, Saudi Arabia, New Zealand, Bolivia, Costa Rica, Chile, Canada, Russian Federation, Slovenia

    Quantity

    1880 Batteries