Philips issued a recall earlier this month on certain sleep and respiratory devices.
This affects specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices.
The majority of the affected devices within the advised 5-year service life are in the first-generation DreamStation product family.
The company issued the recall notification to address identified potential health risks related to the polyester-based polyurethane (PE-PUR-THANE) sound abatement foam component in these devices.
The risks include that the PE-PUR foam may degrade into particles that may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals. The foam degradation may be exacerbated by the use of unapproved cleaning methods, such as ozone,** and high heat and high humidity environments may also contribute to foam degradation.
- 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. To continue use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks identified in the recall notification.*
- For patients using affected life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed therapy until you have talked to your physician. Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks identified in the recall notification.*
To file a claim, visit philipssrcupdate.expertinquiry.com/.
For more information, visit usa.phlips.com
