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.
What to expect during your scheduled remediation
Starting now and over the next several months, a field service engineer will contact you to schedule an appointment.
When the field service engineers are on-site, they will replace the power management PC board. Where possible, other open Field Correction Orders (FCOs) will be performed simultaneously with the power management PC board remediation to minimize disruption.
V60/V60 Plus mitigations
While you await the implement of the technical solution, you can continue to use your V60/V60 Plus ventilators with at least one of the outlined mitigations in the June FSN.
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 implementation of the technical solution.
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 April 2022 and June 2022, Philips sent a further recall notification with updated guidance for customers and users of affected devices.
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:
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 ventilator must be removed from clinical use and serviced by authorized service personnel.
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 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 will be deploying a technical solution based on redesigning the power management PC board that controls the 35V rail powering the ventilator. This solution will enable the ventilator to alarm per design in the event failure. Philips Respironics has begun contacting customers to schedule appointments to implement the technical solution.
Yes, affected customers were notified via a customer notification letter for this recall in March 2022, with updated notifications sent in April 2022 and June 2022 to provide further guidance for customers and users.
Please contact your Philips sales representative with any questions.
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