BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0603-2019 · Initiated November 23, 2018

    Recall

    Recall Number
    Z-0603-2019
    Event Number
    81443
    Firm
    Philips North America LLC
    FEI Number
    1000524572
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 23, 2018
    Terminated
    September 29, 2020
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    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.

    Action

    On 11/23/2018 Urgent Medical Device Recall notices were mailed via USPS certified mail to customers. Customers were instructed to do the following. Inspect the batteries installed in your monitor/defibrillator to determine if they are affected by this recall. If any affected batteries are found, remove them from service immediately, along with any other affected batteries in your inventory. Further, customers were asked to complete and fax the Customer Reply Form to: +1.877.499.7223 or email to [email protected]. Your monitor/defibrillator can only be returned to service once a charged battery, unaffected by this recall, is installed. Firm will replace affected Rechargeable Lithium-Ion Batteries at no charge to the customer. Firm will contact you when replacement batteries are available. Customers with additional questions are encouraged to call 1-800-722-9377. Distributors were advised to send a copy of the Urgent Medical Device Recall notice and Customer Reply form to any customer to whom they have distributed affected batteries.

    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