Philips Respironics
V60 / V60 Plus Ventilators

What you need to know about the removal of the high flow therapy option for Philips Respironics V60 and V60 Plus ventilators in the US

Questions on the High-Flow Therapy market removal? Please contact HFTremoval@philips.com

For specific technical questions, please call the Philips Customer Care Solutions Center at
1-800-722-9377

In 2020, Philips Respironics released the V60 Plus ventilator and a high flow therapy upgrade option for V60 ventilators, under the FDA enforcement policy for ventilators in the US:

The V60 Plus and high flow therapy software upgrade (SW 3.00 or greater) is a modification to the existing FDA-cleared V60 ventilator and is therefore provided for use in accordance with FDA’s guidance, “Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency,” Section IV Policy for Modifications to FDA-Cleared Devices, issued March 2020. The V60 Plus ventilator and high flow therapy upgrade are not FDA cleared.

As of May 11, 2023, the FDA announced the end of the Covid-19 Public Health Emergency. Philips Respironics is following the FDA’s Transition Plan guidance* for medical devices and/or medical device modifications that were released under the enforcement policy for ventilators and accessories, but are not FDA-cleared.

This means Philips Respironics will remove the high flow therapy (HFT or HFT60) software option from all V60 and V60 Plus devices in the US. This does not alter the software version on your devices (3.00, 3.10 or 3.20), and it will not impact device functionality (other than removing the high flow software option). In addition, Philips Respironics will discontinue the AC611 High Flow Nasal Cannula in the US as of November 7, 2023.

How will the software removal process work and can I continue use?

You will be contacted by a local Philips Field Service Engineer, or AuthorizedService Provider, to schedule the removal of the high flow therapy software option from your device(s) via a new Field Change Order (FCO).

The V60/V60 Plus User Manual has been updated to combine all software versions and provide high flow therapy stop use information. Please download the most recent version from www.philips.com/ifu . Please note that at the time of HFT/HFT60 removal, 3.20 software upgrades in the US (FCO86600065) will no longer be necessary. Respironics will make every effort to complete them during the scheduled visit.

Continue Use Conditions

As you are aware, V60/V60 Plus ventilators are currently receiving required safety updates and repairs. You can continue to use high flow therapy in either of the conditions below until HFT has been removed or until November 7, 2023, whichever occurs first.

If you have ventilators that have received the required safety updates and repairs, you can continue use.
If you have ventilators that have not received the required safety updates and repairs, you can continue to use them pursuant to the instructions for use and any additional medical device safety notifications provided by Philips.

Customers can continue to use their inventory of AC611 High Flow Nasal Cannulas until November 7, 2023, at which time the cannulas should not be used.

The V60/V60 Plus User Manual has been updated to combine all software versions and provide high flow therapy stop use information. Please download the most recent version here.

Please continue to visit our website for the latest information, or reach out to your Philips Sales Representative with any questions.

Questions and answers

Was the Philips Respironics V60 Plus ventilator and High Flow Therapy software upgrade sold under the Emergency Use Authorization (EUA) during COVID-19?: No, the Philips Respironics V60 Plus ventilator and High Flow Therapy (HFT) software upgrade for V60 ventilators were not released under the EUA. They were provided for use in accordance with FDA’s, “Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency,” Section IV Policy for Modifications to FDA-Cleared Devices, issued March 2020. The V60 Plus ventilator and High Flow Therapy upgrade were not FDA-cleared.
What is the difference between the Enforcement Policy for Ventilators and the Emergency Use Authorization?: The V60 Ventilators with High Flow Therapy (HFT) and V60 Plus Ventilators were released under the Enforcement Policy which allowed FDA-cleared devices to be modified to support patients with respiratory failure or respiratory insufficiency to be distributed without a prior 510(k) submission, for the duration of the public health emergency.

Ventilators released under the EUA were to address concerns related to insufficient supply of the ventilators and availability of FDA-cleared devices to treat COVID-19 patients without a prior 510(k) submission.
Is the Philips Respironics V60 or V60 Plus ventilator being removed from the US market?: No, the V60 and V60 Plus ventilators can continue to be used in the US per the instructions for use and any additional medical device safety notifications provided by Philips. Use of HFT/HFT60 on these devices must end on November 7, 2023, but use of non-invasive ventilation can continue. NIV is not impacted by the end of the Enforcement Policy for Ventilators and Accessories. Note: this is an FDA guidance and therefore does not govern Canada or any other country outside the US.
Can I continue to use High Flow Therapy after November 7?: Use of High Flow Therapy (including HFT60) after November 7, 2023 will be considered off-label use.
Is the AC611 High Flow Nasal Cannula being discontinued?: The AC611 will be discontinued as of November 7, 2023 in the US.

* Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

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