Philips Respironics Recall Information
Page last updated: 9/3/2021 at 2:30pm
Recent Page Updates
Philips Respironics has received FDA approval for the sound abatement foam in the CPAP devices. This is an important milestone that continues to drive the importance of device registration. PHS continues to encourage patients to register their patient-owned CPAP devices to begin the replacement/repair process through Philips.
PHS was made aware of a respiratory device recall on Monday, June 14. We are working alongside the manufacturer, Philips Respironics, to access updates and develop plans for PHS and COHSC families.
Recall Information from the Manufacturer
Philips Respironics is voluntarily recalling the below devices due to two (2) issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and NonContinuous Ventilators: 1) PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone (see FDA safety communication on use of Ozone cleaners), and off-gassing may occur during operation. Read the full recall notice from Philips Respironics Ventilators here or the Philips Respironics CPAP machines here.