Phillips CPAP Machine

recall-phillips ventilator machines

Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication

You may be eligible for the Phillip CPAP class action lawsuit!

The U.S. Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices (see table below) due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.

If you use one of these affected devices (see table below), talk to your health care provider to decide on a suitable treatment for your condition and follow the recommendations listed below.

Philips Respironics is recalling the following affected devices manufactured between 2009 and April 26, 2021.

You may be eligible for the Phillip CPAP class action lawsuit if you have been diagnosed with the following cancers related to the recall.

* Leukemia
* Breast Cancer
* Lymphatic Cancer
* Liver Cancer
* Nasal Cancer
* Non-Hodgkins's
* Lymphoma
* Brain Cancer
* Multiple Myeloma
* Prostate Cancer
* Bladder Cancer
* Testicular Cancer
* Stomach Cancer
* Hematopoietic Cancer
* Papillary Carcinoma
* Thyroid Cancers

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CPAP, BiPAP Devices & Ventilators

Please see the list below of those machines in question during the Phillip CPAP recall:

 

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FDA Actions

The FDA is working to assure Philips Respironics adequately evaluates the issue with the device, the scope of the recall, and the most appropriate mitigation strategies, including corrective actions by the company.

The FDA is analyzing medical device reports (MDRs) related to the affected devices over the period of 2009-2021 for reports that could be related to this issue.

The FDA does not have evidence at this time that any other CPAP machines, BiPAP machines, or ventilators, from Philips or other manufacturers, are affected.

The FDA will continue to monitor supply and demand to assess availability of the affected devices and any potential shortages.

The FDA will continue to share updates with the public as more information becomes available.

Reporting Problems with Your Device

If you think you had a problem with a CPAP, BiPAP, or mechanical ventilator, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Questions

The FDA posted answers to frequently asked questions about this recall: Philips Respiraonics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions.

For more information on the recall notification, contact your local Philips representative or visit Philips Respironics’ recall notification web pageExternal Link Disclaimer.

More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov.

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