Voluntary Recall Information


Philips Respironics Sleep and Respiratory Care devices

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News and Updates > Ventilation news and updates

Ventilation news and updates

Posted: December 13, 2022
Updated: January 27, 2023

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.

Trilogy Serial Number label location

 

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. 

November 7, 2022

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.  

 

June 1, 2022

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.

 

Based on the normal cadence of monthly patient visits and Philips’ capacity and lead-times, we project that the full remediation process for Trilogy 100/200 repair kits will take approximately 12-14 months to complete.

 

Thank you for your patience and trust throughout the remediation process. We will continue to provide updates to this process as they become available.

 

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April 5, 2022

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”).
 

Philips will provide customers who have registered recalled Trilogy 100/200 models on www.philips.com/src-update with inline bacteria filters to help them provide safer care for patients whose treating physicians advised that they continue therapy on affected devices. Customers who choose to opt-in to the program are eligible to order one (1) pack of in-line bacteria filters (includes ten (10) filters) for each registered Trilogy 100/200 device for each ten-day period until that device is remediated. Please note, customers must first register recalled devices at www.philips.com/src-update indicating their patient will continue to use affected devices.

 

Please reach out to your local sales representative for instructions for how to opt-in to this program. Filters shipped will be in accordance with local regulatory approvals and availability of supply.

 

Please note, filters will not be provided if patients have a Trilogy Evo loaner through the Trilogy Evo loaner program. If you provide a patient a Trilogy Evo loaner device pursuant to the Trilogy Evo Loaner program, no filters will be shipped for that patient using a Trilogy Evo loaner.


Please follow the IFU for the applicable affected device for proper installation and inspection of the inline bacteria filter. As referenced above, you should also follow the IFU for the specific bacteria filter with regard to replacement frequency for that specific filter.

 

We want to reaffirm our commitment to help you navigate the complexities of this recall efficiently and effectively. We will continue to work hard to complete this recall and to provide both you and your impacted patients with the most up-to-date information. If you have any questions, please reach out to your customer sales representative or to Philips clinical support with any questions.

 

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