PHILIPS RESPIRONICS RECALL INFORMATION
We want to make you aware of an important development related to certain CPAPs, BiLevel PAPs, and ventilators (including non-invasive and invasive ventilation) manufactured by Philips Respironics. Please be sure to read this information in detail.
Philips Respironics initially recalled Trilogy 100 and 200 devices on June 14, 2021, and they subsequently began to repair these devices by installing new sound abatement foam. On December 8, 2022, Apria was notified by Philips Respironics of a new nationwide recall of these remediated Trilogy 100/200 ventilator devices.
Affected customers should be aware of the following:
- If you have not yet received a remediated device, please be aware that this new recall is likely to prolong the time it will take for you to receive a remediated device.
- If you have already received a remediated device impacted by the new recall, Apria is working closely with Philips and awaiting further details on their resolution plan. Please carefully review the Field Safety Notice and information provided by Philips on their website. Access the information as follows:
- Go to www.philips.com/src-update and, in the Important updates section, select View all news and updates.
- Select the Ventilation news and update option, dated December 13, 2022.
Additional information will be forthcoming from Apria and/or Philips when available. In the interim, further information or support concerning this issue can be obtained from Philips via their customer service line at 1-800-345-6443. As always, please contact your physician for guidance on your specific clinical needs.
On September 6, 2022, Apria was notified by Philips of a voluntary update to its contraindications and warning labeling pertaining to specific face and nasal masks with magnetic headgear clips or straps.
Please review the notification from Philips in detail.
If you have questions or need support concerning this update, please contact Philips’ customer service line at 1-800-345-6443 in accordance with the direction provided by Philips, and please contact your physician for guidance on your specific clinical needs. Thank you for your attention to this matter.
Also, please see the information provided by the FDA.
On June 14, 2021, Philips Respironics announced a voluntary recall for Continuous and Non-Continuous Ventilators (certain CPAP, BiLevel PAP and Ventilator Devices) due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices. For information, a complete list of impacted products, potential health risks, and to register your device, please visit this page on the Philips website or call 877-907-7508.
Also, please see this information provided by the FDA: