BEUDAMED
    FDA Enforcement Class II Ongoing

    Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual

    Recall: Z-2028-2024 · Reported June 12, 2024

    Enforcement

    Recall Number
    Z-2028-2024
    Event ID
    94618
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Remote Diagnostic Technologies Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2024
    Initiation Date
    May 9, 2024
    Classification Date
    June 6, 2024
    Address
    Farnborough Aerospace Centre, Aerospace Boulevard, Farnborough, N/A, N/A, United Kingdom

    Description

    Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual

    Reason

    Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse.

    Code Info

    00-3020: UDI-DI-07613365002737, Serial Numbers prior to 7022.002871 User/Operator Manual Versions: 41-3007EN-01 and prior

    Distribution

    US Nationwide distribution including in the states of VA, DC, MA, WY, AZ, FL, CA, NM, NJ, TN, OH, KS, IN, NY, IL, TX, NV, NE, PA, AL, IA, GA, MO, KY, WI, OR, CO, WV, WA, ET, UT, ID, OK, MN, ME, MT, MI, NC, ND, MD, DE, VT.

    Quantity

    1745