BEUDAMED
    FDA Recall Open, Classified

    dS Breast 16ch 1.5T

    Recall: Z-0537-2025 · Initiated November 4, 2024

    Recall

    Recall Number
    Z-0537-2025
    Event Number
    95645
    Firm
    Philips North America Llc
    FEI Number
    3016618143
    Product Code
    MOS
    Status
    Open, Classified
    Root Cause
    Use error
    Initiated
    November 4, 2024
    Posted
    November 25, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    dS Breast 16ch 1.5T

    Reason

    Potential safety issue where a patient may be harmed while preparing for or during a scan.

    Action

    An URGENT MEDICAL DEVICE CORRECTION notice dated 10/31/24 was mailed to consignees. Consignees are to continue using affected systems in accordance with the intended use. When using the system follow section PRECAUTIONS, CAUTIONS & WARNINGS in the Instructions For Use (IFU). Consignees are to circulate the recall notice to all users for their awareness of the potential issue. The Recall Response Form is to be provided back to Philips MR within 30 days at [email protected]. Customers with any questions are to contact their local Philips Representative.

    Distribution

    US Nationwide distribution.

    Quantity

    5,231 units