BEUDAMED
    FDA Enforcement Class II Ongoing

    CombiDiagnost R90 is multi-functional general R/F systems.

    Recall: Z-0241-2022 · Reported December 1, 2021

    Enforcement

    Recall Number
    Z-0241-2022
    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

    CombiDiagnost R90 is multi-functional general R/F systems.

    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

    CombiDiagnost R90

    Distribution

    US Nationwide Distribution

    Quantity

    281 in total