Remediation efforts are currently underway to address the power management PC board for Philips Respironics V60/V60 Plus ventilators. Patient safety is our top priority, and we are committed to supporting your ventilation patient care needs through the entire remediation process.
Power Management PCBA Replacement Over the next several months, a Philips Authorized Service Provider (ASP), will contact you to schedule an appointment to replace the power management PC board. While you await the scheduled remediation, you can continue to use your V60/V60 Plus ventilators with at least one of the outlined mitigations provided in the June 2022 FSN.
What to expect during your scheduled remediation When the ASPs are on-site to replace the power management PC board, they will perform any other open Field Correction Orders (FCOs) (such as the removal of high flow therapy), where possible to minimize disruption.
High flow therapy (HFT) software removal across Philips Respironics V60 and V60 Plus ventilators in the US With the end of the COVID-19 Public Health Emergency, the FDA has issued a Transition Plan guidance document* for medical devices and/or medical device modifications that were released under the enforcement policy for ventilators and accessories but are not FDA-cleared. As a result, Philips Respironics will be removing the high flow therapy software option from V60 Plus devices and V60 ventilators with high flow therapy in the US market.
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). Please visit the link below for more information.
Continued service and support Although Philips Respironics has discontinued the V60 and V60 Plus ventilators, we will continue to provide service and support through December 2029 as long as the components remain available.
We understand the challenges this remediation effort has created for clinicians and hospital systems. Thank you for your continued trust and partnership as we work through the remediation process.
In March 2022, Philips Respironics issued a recall notification to customers of its V60, V60 Plus and V680 ventilators, regarding a potential issue that could affect the power management PC board. In May 2022 and July 2022, Philips sent further customer notification letters with updated guidance for customers and users of affected devices. Additionally, an alternative means of ventilation should be available whenever the ventilator is in use. If a fault is detected in the ventilator, disconnect the patient from it and immediately start ventilation with such a device. The original ventilator must be removed from clinical use and serviced by authorized service personnel.
The updated notification advises customers that they must implement one or more of the following actions to mitigate the risk of hazard caused by the power management PC board electric circuit issue:
If customers are unable to implement any of the actions above, they should conduct a risk/benefit analysis to evaluate whether impacted devices should continue to be used.
Philips Respironics is committed to addressing this issue quickly and efficiently, to meet our commitments to our customers and their patients who rely on our respiratory care solutions.
Philips Respironics is deploying a technical solution based on redesigning the power management PC board that controls the 35V rail powering the ventilator. This solution enables the ventilator to alarm, as designed, in the event of failure. If your V60 or V60 Plus device has not yet been remediated, you will receive a call from a Philips Authorized Service Provider to schedule an appointment to implement the technical solution, at your convenience.
Yes, affected customers were notified via a customer product defect alert notification letter for this recall in May 2022 with an update in July 2022 to provide further guidance for customers and users.
If you have any further questions, please contact us at the Philips Customer Care Solutions Center at 1-800-722-9377.
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.
You can find more information on the high flow therapy software removal here.
You can find the latest version of the user manual here.
* 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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