07/23/2021
Important recall notification for Philips sleep and respiratory care device patients:
Dear Device Customer,
Philips Respironics is voluntarily recalling the below devices
All CPAP, APAP, BIPAP & TRILOGY Devices manufactured before 26 April 2021, &
All serial numbers
due to two (2) issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and NonContinuous Ventilators: 1) PE-PUR foam may degrade into particles that may enter the device’s air pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam may off-gas certain chemicals.
The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone (see FDA safety communication on use of Ozone cleaners), and off-gassing may occur during operation.These issues can result in serious injury which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. The potential risks of particulate exposure include: Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic affects. The potential risks of chemical exposure due to off-gassing include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects. There have been no reports of death as a result of these issues.
Immediate Actions to be taken by You, the User:
1. Do not stop or alter your prescribed therapy until you have talked to your physician. Philips
recognizes that alternate ventilator options for therapy may not exist or may be severely
limited for patients who require a ventilator for life-sustaining therapy, or in cases where
therapy disruption is unacceptable. In these situations, and at the discretion of the treating
clinical team, the benefit of continued usage of these ventilator devices may outweigh the
risks.
2. If your physician determines that you must continue using this device, use an inline
bacterial filter. Consult your Instructions for Use for guidance on installation.
3. Register your device(s) on the recall website www.philips.com/src-update
a. The website provides you current information on the status of the recall and how to
receive permanent corrective action to address the two (2) issues.
b. The website also provides you instructions on how to locate your device Serial Number
and will guide you through the registration process.
c. Call 1-877-907-7508 if you cannot visit the website or do not have internet access.
Permanent Corrective Action to be Taken by the Company:
Philips is deploying a permanent corrective action to address the two (2) issues described in this Recall
Notice. As part of the registration process above, you will be provided information on the next steps to
implement the permanent solution.
Other Information:
If you need any further information or support concerning this recall/issue, please contact the recall
support hotline or visit the website:
1-877-907-7508
www.philips.com/src-update
Adverse reactions or quality problems experienced with the use of this product may be reported to the
FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or fax.
This notice has been reported to the appropriate Regulatory Agencies.
Philips regrets any inconveniences caused by this problem.
Sincerely,
Rodney Mell
Head of Quality and Regulatory
Philips Respironics - Sleep & Respiratory Care
--
Chris Abernathy
Deans Medical
Dme Manager
Sleep and respiratory care updates
