Medical technology equipment giant Philips has issued a voluntary recall for millions of the brand’s sleep apnea machines and ventilators. The U.S. Food and Drug Administration (FDA) noted that the purpose of the recall was to “mitigate potential health risks related to the sound abatement foam component” of the devices.
The reason for recall
The biggest factor in this decision was the discovery of a toxic foam that is used in the breathing devices and its potential danger if ingested or inhaled by users. The foam may also give off chemical emissions. Exposure to foam particles or emissions is potentially toxic, the manufacturer said, and may cause cancer, along with other unknown health risks.
An estimated 3 million to 4 million devices globally have been placed on recall, 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.
Note: DreamStation 2 products are not affected by the recall.
Philips has not released any reports of deaths, but it is aware of consumers finding discolored debris within the air-path tube and feeling sick after use.
Potential risks from exposure to the foam include: headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects. Risks from chemical exposure include: headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects. The company hasn’t received reports about patient exposure to chemical emissions.
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
For patients using affected BiLevel PAP and CPAP devices: Discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment.
For patients using affected life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed therapy until you have talked to your physician.
Sleep apnea is a common condition that occurs when the upper airway becomes blocked during sleep, reducing or stopping airflow. Researchers from Michigan Medicine’s Sleep Disorders Centers analyzed Medicare claims of more than 50,000 Medicare beneficiaries ages 65 and older who had been diagnosed with OSA.
Unfortunately, the risk for sleep apnea increases as you get older. According to the CDC, Sleep apnea may affect between 38 percent and 68 percent of people over 60.
A mechanical device such as a CPAP machine can be used to treat sleep apnea by pumping air through a tube into a mask worn by a person with sleep apnea.
Centers for Disease Control and Prevention. (n.d.). Preventing Chronic Disease. Centers for Disease Control and Prevention. https://www.cdc.gov/pcd/issues/2012/11_0117.htm.
Franklin, K. A., & Lindberg, E. (2015). Obstructive sleep apnea is a common disorder in the population-a review on the epidemiology of sleep apnea. Journal of thoracic disease, 7(8), 1311–1322. https://doi.org/10.3978/j.issn.2072-1439.2015.06.11