BEUDAMED
    FDA Recall Open, Classified

    (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)

    Recall: Z-0715-2024 · Initiated July 15, 2021

    Recall

    Recall Number
    Z-0715-2024
    Event Number
    93739
    Firm
    Philips North America
    FEI Number
    3006648320
    Product Code
    LNI
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    July 15, 2021
    Posted
    January 11, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2296

    Description

    (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)

    Reason

    The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. caused by a power outage on site.)

    Action

    Starting in July 2021, Philips Field Service Engineers (FSE) visited impacted customer sites to inspect the affected systems and turn on the circuit breaker of the extended battery of the UPS where required. All impacted systems were addressed as of February 9, 2023. Instructions for manufacturing and installation were updated on October 31, 2020, which included more detailed instructions for the correct setting of the circuit breaker.

    Distribution

    Domestic distribution to the following states and territories: CA DE FL GA IL KY MA ME MI MO NH NJ NM NY OH PA SC TN TX VA VT WI WY, and PR. International distribution worldwide.

    Quantity

    56 US; 169 ROW