On June 14, 2021, Philips recalled millions of Bi-Level PAP, CPAP and mechanical ventilator devices after identifying potential health risks related to degradation of the machine’s sound abatement foam. The majority of the Recalled Devices are in the first generation DreamStation product family.
Your doctor may have prescribed you one of the Philips CPAP or Bi-Level PAP devices for home use as treatment for sleep apnea. CPAP and Bi-Level Pap machines are used to ensure that you maintain continued breathing while asleep.
The foam used in the Philips machines is composed of a poly-ester based polyurethane (PE-PUR) material. The foam may degrade into particles that enter the device’s air pathway and can be ingested or inhaled by the user. The foam may also emit certain harmful chemicals as it degrades.
Possible Health Risks
The potential risks of particulate exposure include serious toxic and carcinogenic effects, including:
Patients with a history of consistent use and a diagnosis of throat, esophageal, and lungcancer may be particularly at risk.
All Recalled Devices were manufactured before April 26, 2021. The majority of the Recalled Devices are in the first generation DreamStation product family.