BEUDAMED
    FDA Enforcement Class II Ongoing

    Infa-Therm Transport Mattress, Reference Number 989805616831 1015

    Recall: Z-0505-2022 · Reported January 26, 2022

    Enforcement

    Recall Number
    Z-0505-2022
    Event ID
    89173
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 26, 2022
    Initiation Date
    November 26, 2021
    Classification Date
    January 18, 2022
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2289, United States

    Description

    Infa-Therm Transport Mattress, Reference Number 989805616831 1015

    Reason

    After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

    Code Info

    All units are impacted

    Distribution

    US Nationwide and Canada

    Quantity

    141,744 units (Updated to 141,750 units as of 2/15/22)