Philips issued a voluntary recall for millions of its sleep apnea machines and life-sustaining ventilators after it found that foam used in the breathing devices may degrade into particles and be ingested or inhaled by users.
Philips says they will continue to monitor reports of potential safety issues as required by medical device regulations and laws in the markets in which it operates. The foam may also give off chemical emissions. Exposure to foam particles or emissions is potentially toxic, the manufacturer said and may cause cancer, among other health risks. To date, there have been no reports of death as a result of these issues.
The recall involves an estimated 3 million to 4 million devices globally, based on the company’s production and shipment data. Over half of the devices were sold in the U.S., with the majority of them being the first-generation DreamStation products.
“We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety,” said Frans van Houten, CEO of Royal Philips. “In consultation with the relevant regulatory agencies and in close collaboration with our customers and partners, we are working hard towards a resolution, which includes the deployment of the updated instructions for use and a comprehensive repair and replacement program for the affected devices. Patient safety is at the heart of everything we do at Philips.”
List of recalled Philips CPAP machines, ventilators
- E30 (Emergency Use Authorization)
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C Series ASV, S/T, AVAPS
- OmniLab Advanced Plus In-Lab Titration Device
- SystemOne (Q series)
- DreamStation CPAP, Auto CPAP, BiPAP
- DreamStation GO CPAP, APAP
- Dorma 400, 500 CPAP
- REMStar SE Auto CPAP
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
- Garbin Plus, Aeris, LifeVent Ventilator
- A-Series BiPAP V30 Auto Ventilator
The company is sending letters to users with instructions for registering online to have affected devices repaired or replaced. Anyone who doesn’t receive a letter should call Philips at 877-907-7508.
Philips is advising those with affected devices to discontinue using them and work with a doctor to determine the best option for next steps of treatment. Dr. Fox may be of help with a temporary appliance for treatment, or consideration with your physician if oral appliance therapy could be an option as an alternative treatment for obstructive sleep apnea.
Contact Fox Dental with any questions or to schedule a consultation.