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

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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