On June 14, 2021, Phillips issued a voluntary recall notification of positive air pressure (PAP) and ventilator devices. The recall applies to all Phillips devices manufactured before April 26, 2021, including the original DreamStation line of CPAP machines. This recall does not apply to the newer DreamStation 2 CPAP machines, nor does it extend to devices of other PAP manufacturers.
The foam within select devices used to diminish noise from the machine may break down into small particles. These particles may then enter the device air pathway and be ingested or inhaled by the PAP user. In addition, the foam may degrade into volatile chemicals (Toluenes) that are potentially toxic. Phillips has noted that use of certain ozone cleaning products, high temperature, and humidity may contribute to the degradation of the foam in the devices and thus should be avoided.
Philips Respironics has stated that 0.03% of patients reported symptoms such as headache, upper airway irritation, cough, chest pressure, and sinus infection but the manufacturer stated that it has “not received reports of patient impact or serious harm as a result of this issue.” Nonetheless, there is a possibility of serious injury that can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment.
For Life-sustaining Mechanical Ventilator Devices: Do not stop or alter prescribed therapy on affected life-sustaining mechanical ventilator devices without consulting with a physician. Philips advises patients who must continue using a recalled, life-sustaining mechanical ventilator device to use an inline bacterial filter.
For BiLevel PAP and CPAP Devices: Phillips has recommended to discontinue use of devices AND to consult with a doctor to determine the most appropriate options for continued treatment, based on the benefits of continuing therapy and potential identified risks.
- For those with severe sleep apnea, significant sleepiness, or cardiovascular disease, or those whose occupational safety depends on alertness, a consult with the prescribing doctor is vital as for some, continued use may be selected.
- Alternative options to PAP may be available for some patients, including oral appliance therapy, positional therapy, and surgery.
Patients, Caregivers, Users: Phillips has established a webpage to register your device, look up the device serial number, and begin a claim if the unit is affected. To date, no timeline for remediation has been released.Please also visit this Phillips webpage for information regarding the recall or call Phillips at 877-907-7508.
Physicians: The American Academy of Sleep Medicine has also issued guidance and a decision tree for patient counselling.
