BEUDAMED
    FDA Enforcement Class II Ongoing

    Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.

    Recall: Z-2025-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-2025-2023
    Event ID
    92448
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DRE Medical Group Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 5, 2023
    Initiation Date
    May 15, 2023
    Classification Date
    June 28, 2023
    Address
    2601 Stanley Gault Pkwy Ste 101, N/A, Louisville, KY, 40223, United States

    Description

    Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.

    Reason

    Devices were imported with Japanese Language and NIST Oxygen Gas Fittings and retrofitted, may pose a serious health risk as the gas pathway of these devices may be contaminated.

    Code Info

    USI-DI: 00884838009868 Serial Numbers: Serial Number 100043954 100050078 100052760 100052848 100054619 100054626 100055277 100055557 100058549 100058566 100058837 100058995 100060228 100065373 100069520 100070487 100071122 100072691 100078379 100080232 100080844 201003462

    Distribution

    US: CA, FL

    Quantity

    22 units