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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.

CPAP OR BILEVEL MACHINES

Patient families with CPAP or BiLevel Machines

For the replacement process to begin, patients must register their device on the Philips website. Watch the video below to walk you through the registration process.

Registering your device:

  1. If you or your child is using a device that is included in the voluntary recall, contact your physician to discuss the next steps.
  2. Go online or call Philips Respironics to register your device, 800-345-6443.
  3. Keep PHS updated on your status. If you contact Philips Respironics due to particulates or gasses, please follow up with the PHS customer service team so we can document in the patient’s chart.

If you have already registered your equipment:

Philips Respironics announced they have started sending replacement machines out to patients who use the device for CPAP and auto-CPAP purposes only. There is currently no set timeline for when patients can expect to receive their device due to the volume of replacements required due to this recall.

When you receive the machine, it will include two documents instructing you on how to clean and inspect your new machine as well as how to return your existing machine for disposal.

TRILOGY 100 OR 200 VENTILATORS

Patient families with Trilogy ventilators (100 or 200)

PHS has registered PHS Trilogy 100 and 200 ventilators through Philips Respironics to ensure equipment is on the list for repair/replacement. You do not need to register PHS ventilators.

NEXT STEPS- PHS

Everyone at Pediatric Home Service is proud to support the medically complex population. It is a responsibility and an honor we have taken seriously for the past 30 years. We understand the concern a recall can bring and are committed to your child’s continued safety in the home. We are committed to consistent communication and updates. Please use this site to stay current on PHS’s plans based on manufacturer guidelines. Our current focus is on building the list of impacted devices to register with Philips Respironics on behalf of our patient families.

Please continue to communicate with the PHS team at 800-225-7477 if you have any immediate unmet needs or have questions. We will do our best to support our patients as Philips Respironics works to identify the solutions.

The below communications have been sent out to impacted PHS patient families:

  1. Patient email- English
  2. Patient email- Spanish