Update: Nov. 30, 2021
Dear Patient,
Penn Medicine has been made aware of a medical device recall by Philips Respironics, the company that manufactured your BiPAP, CPAP or mechanical ventilator device.
On Monday June 13, 2021, Philips Respironics issued a recall of the vast majority of their sleep apnea devices, including all SystemOne, DreamStation, Trilogy 100, and Trilogy 200 devices. This recall does not include the Trilogy Evo or oxygen equipment.
There is a significant chance the CPAP or BiPAP device you are using is included in this recall. Therefore, it is important to take appropriate steps in response to this information. If your device was manufactured by ResMed, then the contents of this message do NOT apply to you and you can safely continue to use your device. If you are unsure about if your unit is on the Philips recall list, please contact your equipment company.
More information on the included devices can be found on the Philips website and FDA website. Those websites are updated as new information becomes available.
Why the Devices Have Been Recalled
These devices have been recalled due to concern for the breakdown of the PE-PUR sound abatement foam used inside the machine to make it quieter.
This breakdown is more likely to happen if exposed to certain cleaning products, life ozone cleaners, or high heat and humidity. If a breakdown like this happens, some of the particles or gases may enter your body through the tubing that connects to the mask, and have an effect on, at least, but not limited to, your respiratory health.
The short and long-term impact of inhaling these particles and chemicals is not fully known. Some of these compounds may be carcinogenic, however, no data has been published regarding how time of exposure reduces or increases this risk. No life-threatening events have been reported. The company has shared that the reported number of complaints related to the use of Philips devices is 0.03%. More information is available on the Philips recall website and from the U.S. Food and Drug Administration.
What You Should Do
Confirm and register your device
- Please confirm if your device is affected by visiting the Philips website or contact your equipment company.
- Register your device on the recall website as soon as possible. Philips has started an online registration process for all users that will allow your device to be included in any future remediation program the company will develop.
Continue use by device type
- For patients on a ventilator (Trilogy 100, Trilogy 200, or EVO) DO NOT DISCONTINUE THERAPY AT ANY TIME as stopping treatment may impose significant risk to your health, including death. Please contact your provider to discuss your case in further detail or make a follow-up appointment at your earliest convenience.
- For patients on BiPAP, do not discontinue use of your device until you contact your provider or make a follow-up appointment by sending a myPennMedicine message or calling your doctor's office.
- For patients on CPAP, you should continue therapy until an appropriate and safe alternative is found.
Clean and care for your device
- Do not use any ozone-based or UV light cleaning system or any other unapproved cleaning agents as this may increase any health risks associated with this recall or improper device cleaning. Read an FDA safety communication on the risks associated with ozone-based and UV light cleaning.
- Keep the equipment in a temperature-controlled room, like a bedroom or living room.
Masks, supplemental oxygen and non-FDA approved devices
- If your mask is manufactured by Philips Respironics, you can continue to use it, as it is not part of this recall.
- If you are using supplemental oxygen, you can and should continue to use it as the oxygen concentrators and other oxygen delivery devices are not part of this recall and do not impose a risk.
- Sleep devices are manufactured by a limited number of FDA-approved companies. Some of these companies are actively ramping up their production and distribution, to fill the void left by this recall. In the event of a device shortage, we strongly discourage the purchase of non-FDA approved devices online or in retail stores, as we do not have any information regarding their manufacturing process or effectiveness in treating your sleep disorders.
Philips Respironics is working to resolve this issue. Corrective actions taken by Philips include the deployment of updated instructions for use and a repair and replacement program for affected devices.
Philips is aiming to address all affected devices as expeditiously as possible. Visit the Philips website to stay informed of up-to-date information about how Philips will manage this recall and what options will be offered in the near future to repair or replace your device.
How Penn Medicine Can Help
We at Penn Medicine do not have information yet on the timing or details of repair or replacement of devices. This is a worldwide recall of the listed Philips CPAP and breathing type devices, and there currently is a general shortage of all brands of new and replacement devices. We are here to support you as much as possible and will be working with your Durable Medical Equipment companies as we learn more. Please understand that this is a fluid situation and our recommendations may or may not change as more data is shared by the manufacturer, medical professional societies, and government regulatory agencies. This statement will be updated accordingly.
If you have any questions, please do not hesitate to contact your doctor's office for medical questions and your equipment company for equipment questions. You may also send us non-urgent questions through myPennMedicine.