BEUDAMED
    FDA Enforcement Class II Ongoing

    DigitalDiagnost C90

    Recall: Z-0239-2022 · Reported December 1, 2021

    Enforcement

    Recall Number
    Z-0239-2022
    Event ID
    89023
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Healthcare
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    December 1, 2021
    Initiation Date
    September 22, 2021
    Classification Date
    November 24, 2021
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032, United States

    Description

    DigitalDiagnost C90

    Reason

    The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied.

    Code Info

    DigitalDiagnost C90

    Distribution

    US Nationwide Distribution

    Quantity

    281 in total