Voluntary Recall Information

Update related to Trilogy Evo platform of ventilators

Some Trilogy 100/200  and V60/V60 Plus users impacted by Philips Respironics recalls may be using the Trilogy Evo platform of ventilators as an alternative. Please  be aware of recent important product updates related to the Trilogy Evo platform of devices. Please note, when the mitigating actions specified in the Field Safety Notices are taken:

• Trilogy Evo continues to be an alternative for Trilogy 100 and Trilogy 200 devices impacted by the June 2021 recall of certain CPAP, BiPAP and mechanical ventilators related to PE-PUR sound abatement foam
• The Trilogy EV300 continues to be an alternative for Philips Respironics V60 and V60 Plus devices impacted by an issue related to the power management PC board
• The Trilogy Evo platform continues to be an alternative for new patients needing treatment

For more information on the March and April 2023 field safety notices related to the Trilogy Evo platform of ventilators, please click here.

Update related to Trilogy 100/200 repairs

Following the preparations and relevant clearances, the repair of Trilogy 100/200 ventilators (approximately 3% of the registered affected devices globally) has started in recent months. To date, we have remediated a limited number of registered Trilogy devices. Philips Respironics has detected two issues with these corrected Trilogy 100/200 ventilators following a limited number of complaints. 

Post market surveillance data indicate that silicone sound abatement foam installed in reworked Trilogy 100/200 devices may potentially separate from the plastic backing to which it is adhered. Separation of the foam could impact the performance of the device by potentially blocking the air inlet and thus lowering the inspiratory pressure. This issue only affects the Trilogy 100/200 ventilators that have already been repaired. Additionally, Philips Respironics has observed residual PE-PUR sound abatement foam in some devices that were returned to the field. These cases were limited but further exposure to PE-PUR sound abatement foam should be avoided.

These problems do not affect any of the DreamStation CPAP or BiPAP sleep apnea devices that have been remediated and distributed to patients or homecare providers.

While Philips Respironics works to resolve these issues, the company has temporarily suspended the repair of Trilogy 100/200 devices.

Patient safety is our top priority, and we are steadfast in our commitment to quickly investigate, identify and address any potential corrections. For more information regarding these identified issues, and to understand the actions you need to take, please read the complete Field Safety Notice below. We will provide you with additional information as it is available. 

Questions and Answers

Will these issues affect other remediated Philips Respironics CPAP, BiPAP, and ventilator devices?
These issues do not affect any of the DreamStation CPAP or BiPAP sleep apnea devices that have been remediated. The remediation process for Trilogy 100/200 devices differs from the remediation process for all other affected devices. Given this, and the nature of the issue, we are confident that these issues are isolated to the remediated Trilogy 100/200 devices only. 

Why is the remediation process different for Trilogy 100/200 compared to affected CPAP and BiPAP devices?
The design of the Trilogy 100/200 devices differs from the design of other CPAP and BiPAP devices affected by the recall. An adhesive is required to hold the sound abatement foam in place on the air inlet assembly. This adhesive is not necessary in other CPAP and BiPAP devices, which is why they are not affected by the foam delamination issue. 

How did this happen? Why should I trust your remediation process of Trilogy 100/200?
Our promise to our patients and customers is that we take action whenever a solution begins to fall short of the highest industry standards. We recognize the challenges this recall has created for you and the affect it has on your business and resources. In this case, our quality and complaint systems operated as intended and we were able to halt shipments as soon as we were aware of a potential issue with remediated Trilogy 100/200 devices. Philips Respironics remains committed to providing safe devices to all registered patients and correcting this issue will allow us to continue to remediate devices effectively.

How can customers identify affected units?
A list of equipment affected by this issue is included with this letter. The devices are identified by Serial Number. The Serial Number is located on the bottom of the Trilogy Ventilator.

When will you restart the process of remediating the Trilogy 100/200 devices? 
We understand the burden these issues put on your business and resources. Philips Respironics is developing a permanent corrective action in coordination with competent authorities. Once available, Philips Respironics will contact you to begin the correction process. 

Trilogy 100/200 ship hold - Customer update

Philips Respironics has temporarily paused its Trilogy 100/200 remediation program while we investigate a limited number of complaints on remediated Trilogy 100/200 units.   

We anticipate a several week delay from our initial 4-6 week timeline in providing remediated devices back to our customers. Remediating these devices in a timely manner is our top priority, in order to keep remediation progressing once our investigation is complete, please continue to return product that is not currently in-use. 

Providing safe and effective devices for patients and timely completion of remediation is very important to Philips Respironics.  We will continue to provide you with updates as more information becomes available. 

Trilogy remediation step-by-step guide

As soon as we resume the Trilogy 100/200 remediation program, we want to provide our customers with support in understanding how we are handling the process and knowing what to expect.  

Please use our Trilogy remediation step-by-step guide found here for guidance on the registration and remediation process as well as what to expect when you receive a remediated device.  

Trilogy Remediation Update for Business Customers

We are excited to share that Philips is beginning the rework of affected Trilogy 100/200 devices at Philips Service Centers and designated remanufacturing sites. Initially, we will only be offering this service through Philips, and will continue to work to expand to additional Service Centers to accelerate remediation.

To help maintain continuity of patient therapy and remediate these devices as efficiently as possible, we need our business customers’ help to exchange Trilogy devices to Philips each month in order to reach 100% of patients over the next year. Assuming approximately 10% of our customers’ Trilogy devices are returned each month, we estimate that the remediation timeframe for devices will be approximately 4 weeks per device including ship time to and from Philips.

Information for business customers on Bacteria Filters for Trilogy 100 and 200

In circumstances where a physician determines that a patient should continue use of the affected ventilator device, Philips offers bacteria filters to reduce exposure to sound abatement foam particulate in conjunction with the advice of a physician. 

Bacteria filters should be used in accordance with the affected device’s Instructions for Use (IFU). While use of such filters may reduce exposure to degraded sound abatement foam particles, bacteria filters will not reduce exposure to potential volatile organic compounds (“VOCs”).