BEUDAMED
    FDA Enforcement Class II Terminated

    Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,

    Recall: Z-0070-2022 · Reported October 13, 2021

    Enforcement

    Recall Number
    Z-0070-2022
    Event ID
    88625
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Ultrasound Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 13, 2021
    Initiation Date
    August 19, 2021
    Classification Date
    October 7, 2021
    Termination Date
    September 6, 2024
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431, United States

    Description

    Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,

    Reason

    Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power.

    Code Info

    Affected Serial Numbers/UDI numbers: USD1410130 /N/A, US12110905 /(01)00884838097971(21)US12110905, US12110906 /(01)00884838097971(21)US12110906, US12111049 /(01)00884838097971(21)US12111049, US31310191 /N/A, US31511242 /N/A, US32111072 /(01)00884838097971(21)US32111072, US41210049 /N/A, US42111774 /(01)00884838097971(21)US42111774, US51210186 /N/A, US62011642 /(01)00884838028098(21)US62011642, US71810505 /(01)00884838028098(21)US71810505, US72011713 /(01)00884838028098(21)US72011713, US72011714 /(01)00884838028098(21)US72011714, US82010111 /(01)00884838028098(21)US82010111, US91410757 /N/A, US92010327 /(01)00884838028098(21)US92010327, US92010512 /(01)00884838028098(21)US92010512, USD2011313 /(01)00884838097971(21)USD2011313, USD2011314 /(01)00884838097971(21)USD2011314, USD2011362 /(01)00884838097971(21)USD2011362, USD2011363 /(01)00884838097971(21)USD2011363, USD2011480 /(01)00884838097971(21)USD2011480, USD2011481 /(01)00884838097971(21)USD2011481, USD2011482 /(01)00884838097971(21)USD2011482, USD2011483 /(01)00884838097971(21)USD2011483, USD2011578 /(01)00884838097971(21)USD2011578, USD2011622 /(01)00884838097971(21)USD2011622, USD2011623 /(01)00884838097971(21)USD2011623, USN1510828 /N/A, USN2011691 /(01)00884838097971(21)USN2011691, USO1210225 /N/A, USO2011257 /(01)00884838097971(21)USO2011257, USO2012052/ (01)00884838097971(21)USO2012052

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of CA, MA, MD, MI, MS, NC, NY, OH, VA, WA and the countries of Australia, Portugal, Netherlands, Canada, Netherlands, Germany.

    Quantity

    34 units