Philips' CPAP Recall: What You Need to Know!

In June 2021, Philips Respironics announced a voluntary recall for certain sleep and respiratory care devices, predominantly Continuous Positive Airway Pressure (CPAP) machines, due to potential health risks associated with the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices. Users of the affected devices need to be aware of the reasons behind the recall, the models that are affected, the associated health risks, and the recommended steps to take if they have a recalled device.

Reasons Behind the Recall

The recall was prompted by potential health risks posed by the PE-PUR sound abatement foam, which is used to reduce noise during the operation of the devices. Philips discovered that this foam could degrade into particles that may enter the device’s air pathway and be inhaled or ingested by the user. Additionally, the foam can off-gas certain chemicals, potentially releasing them into the device's air pathway.

The health risks posed by inhaling or ingesting foam particles or experiencing exposure to these chemicals include:

• Irritation to the skin, eye, and respiratory tract

• Inflammatory response

• Headache

• Asthma

• Adverse effects on other organs, such as the kidneys and liver

• Possible toxic and carcinogenic effects

Affected Models

The recall affects several models of Philips' CPAP, Bi-Level PAP, and mechanical ventilator devices. The most notable devices within the CPAP and Bi-Level PAP range include the DreamStation first generation, SystemOne Q series, C Series ASV, C Series S/T and AVAPS, and OmniLab Advanced+ in-lab titration devices.

This recall does not include the DreamStation 2 CPAP devices, as these are built with a different sound abatement foam that, according to Philips, meets the updated material safety standards.

Steps for Users

If you are using a Philips CPAP or Bi-Level PAP device, it is crucial to take the following steps:

1. Identify Your Device

Verify if your device is part of the recall by checking the device label for the name, model, and serial number, then compare these details with the information provided on the Philips recall webpage.

2. Register Your Device

Use Philips' dedicated registration process to initiate a claim if your device is affected. This can typically be done through an online portal set up by Philips for the recall.

3. Contact Healthcare Provider

Discuss the best course of action with your healthcare provider. Do not discontinue the use of your CPAP, Bi-Level PAP, or any ventilator device before seeking their advice, as the benefits of continuing therapy may outweigh the risks associated with the recall.

4. Follow Philips' Recommendations

Philips may offer repair or replacement programs for the affected devices. Follow their guidelines for either getting your device serviced or obtaining a new one.

5. Engage in Regular Follow-Up

Keep abreast of any updates regarding the recall and maintain regular communication with your healthcare provider to ensure you're following the appropriate recommendations for your health situation.

Staying Informed and Safe

Philips has stated that they are working closely with regulatory authorities and have rolled out comprehensive plans to address the issues presented by the recall. Users of the affected devices should stay informed of the latest company announcements and official health advisories.

By taking the necessary precautions and following the steps outlined above, patients can continue to manage their sleep apnea while ensuring their safety concerning the Philips CPAP recall.