URGENT: Philips Respironics Medical Device Recall Continuous Positive Airway Pressure (CPAP) and Bi-Level Positive Airway Pressure (BiPAP) Devices

noise canceling foam
Risk of deterioration and emissions of volatile organic compounds
To customers purchasing medical devices,
Philips Respironics is voluntarily recalling the devices below due to two (2) issues with the polyester-based polyurethane (PUR-PE) noise canceling foam used in Philips continuous and non-continuous ventilators: 1) the foam of PUR-PE can break down into particles that can enter the air circuit of the device and be ingested or inhaled by the user; and 2) PUR-PE foam can release certain chemical gases. Foam deterioration may be exacerbated by the use of unapproved cleaning methods, such as ozone (see FDA safety communication regarding the use of ozone-based cleaners). In addition, gases may escape during initial start-up and may continue to evolve throughout the useful life of the device.
These problems can lead to serious injuries that may be life-threatening, cause permanent damage, or require medical intervention to prevent permanent damage. To date, Philips Respironics has received several complaints regarding the presence of black particles or debris in the airway (consisting of the device outlet, humidifier, tubing and mask). Philips also received reports of headache, upper respiratory tract irritation, cough, chest pressure and sinus infection. Risks from particulate exposure include: irritation (skin, eyes and respiratory tract), inflammatory response, headache, asthma, adverse effects on other organs (e.g. kidneys and liver) and toxic carcinogenic effects. Risks from chemical exposure due to off-gassing include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects . No fatalities have been reported as a result of these issues.
All devices manufactured before April 26, 2021
All serial numbers
Continuous Ventilator, Minimal Respiratory Support, Institutional Use
E30 (emergency use authorization)
Continuous ventilator, no life support
DreamStation ASV
DreamStation ST, AVAPS
SystemOne ASV4
C-Series ASV
C-Series S/T and AVAPS
OmniLab Advanced+
Non-continuous fan
SystemOne (Q-Series)
DreamStation
DreamStation Go
Sleep 400
Sleep 500
REMstar SE Auto
Immediate actions to be taken by you, the user:
1. Stop using your device and work with your physician or durable medical equipment (EMD) supplier to determine the most appropriate options for continuing your treatment. To continue using your device due to a lack of alternative options, consult your physician to determine whether the benefits of continuing treatment with your device outweigh the risks outlined in this letter.
2. Register your device on the recall website : www.philips.com/src-update
has. The website provides you with up-to-date 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 with instructions on how to find your device's serial number and will guide you through the registration process.
vs. Call 1-877-907-7508 if you cannot visit the website or do not have Internet access.
Permanent corrective measures that will be adopted by the company:
Philips is currently deploying a permanent corrective action to resolve the two (2) issues described in this recall notice. As part of the registration process above, you will receive information on the next steps to implement the permanent solution.
Other informations :
If you require further information or support regarding this issue, please contact Recall Helpline or visit the website:
1-877-907-7508
www.philips.com/src-update
This notice has been forwarded to the appropriate regulatory agencies.
Philips regrets any inconvenience caused by this issue.
Cordially,
Rodney Mell
Manager, Quality and Regulatory
Philips Respironics – Respiratory and sleep care