Philips Respironics Recall – What DME Providers Can Expect

respironics recallThe Philips Respironics recall notification impacts:

  • Bi-Level Positive Airway Pressure (Bi-Level PAP) devices 
  • Continuous Positive Airway Pressure (CPAP) devices 
  • Mechanical ventilator devices

Most of the recalled machines are part of the first-generation DreamStation product line. The recall doesn’t impact the latest DreamStation 2 devices.

The voluntary recall is because of potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component. The foam component may degrade over time and could enter the patient’s airway. 

Repair and Replacement Program 

Philips is beginning a repair and replacement program. Any repaired machines will receive a new material to replace the sound abatement foam. Additionally, the company is increasing the production of their DreamStation 2 CPAP machines.

What Can DME Providers Expect from the Philips Respironics Recall?

Philips has created a claims processing and support center to help DME providers during the repair and replacement program. You can begin the Philips recall registration process here

Your Recall Letter 

By June 23, 2021, you will receive a letter from Philips with your login credentials to access the registration website. If you don’t receive their letter, you can contact them by phone at 877-907-7508. 

Actions to Take Regarding the Philips Respironics Recall

If customers contact you regarding the recall, Royal Philips advises anyone who has one of the recalled devices to take the below steps.

BiLevel PAP and CPAP Devices 

  1. Discontinue using your Philips Respironics device.
  2. Contact your medical professional or a DME provider to find a replacement option.
  3. If there’s no replacement option available, talk to your medical professional to determine if you should continue to use the recalled machine.

Life-Sustaining Mechanical Ventilator Devices 

  1. Talk to your medical professional before stopping or alerting your treatment.
  2. If an alternative device is not available, your medical professional will determine if you should discontinue using the device. 
  3. If you continue to use the recalled machine, use an inline bacterial filter with your device. 

Potential Risks of Using the Recalled Devices 

The PE-PUR sound abatement foam component could break apart over time and enter the machine’s air pathway. If that happens, it can cause the patient to inhale or ingest the foam pieces. Additionally, the foam pieces may contain off-gas chemicals and cause chemical exposure. 

Side Effects of Ingesting/Inhaling the Foam Pieces

  • Headaches
  • Irritation
  • Inflammation
  • Respiratory issues
  • Possible toxic and carcinogenic effects

Side Effects of Chemical Exposure from the Foam Pieces

  • Headache
  • Hypersensitivity
  • Irritation
  • Nausea/vomiting
  • Possible toxic and carcinogenic effects

Additional Resources Regarding the Philips Recall

Here are links to additional information on the recall regarding the Philips Respironics devices.

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