BEUDAMED
    FDA Recall Terminated

    Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017

    Recall: Z-1271-2020 · Initiated September 10, 2019

    Recall

    Recall Number
    Z-1271-2020
    Event Number
    84850
    Firm
    Philips North America LLC
    FEI Number
    1000524572
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 10, 2019
    Terminated
    April 29, 2024
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017

    Reason

    Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.

    Action

    On 09/11/2019, the firm sent an "Customer Information Medical Device Recall" notification to customers via Certified Mail informing them that certain models of their Automated External Defibrillator (AED) contain a Printed Circuit Assembly (PCA) manufactured by a supplier that did not follow specific procedures when repairing PCAs that initially failed required testing. After being repaired, these PCAs passed all testing at the supplier's facility prior to being assembled into AEDs. The Recalling Firm's quality standards require that the PCAs both be repaired according to specified procedures and pass testing. The Recalling Firm states that the serial number of the AED is printed on the label on the back of the device. The Recalling Firm will replace the affected devices at no charge and while awaiting for the replacement AED, the customer may continue to use the device. The Recalling Firm or distributors will contact customers to arrange for replacement and removal of affected devices. For any additional questions/information, consumers can contact the Recalling Firm at (800)263-3342 option 5 to speak with a AED Recall Team or email [email protected]

    Distribution

    HeartStart FRx: US - CA, CT, FL, IL, MO, NY,TN, TX and WI OUS - Australia, Brazil, Canada, Germany, Italy, Japan, South Korea, Norway, Switzerland and Taiwan. HeartStart HS1: US - CT, FL, IL, MI, MS, NJ, TN, TX, WA and WI OUS - Argentina, Australia, Canada, France, Germany, Hong Kong, Italy, Japan, Netherlands, Norway, Spain, Sweden, and Taiwan

    Quantity

    44 units