Dreamstation 2 Programming

[Gregory Monty]

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Philips Respironics (Philips) DreamStation devices help people with breathing conditions keep breathing at a regular rhythm. They are used both in hospitals and health care settings as well as by people in their homes. The DreamStation can provide both continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) support.

Philips is recalling certain reworked Philips DreamStations because some devices were assigned incorrect or duplicate serial numbers during initial programming. This duplication can cause therapy to be delivered using the wrong prescription or factory default settings. Additionally, it may fail to deliver any therapy at all. There is no warning or indication to the user that the DreamStation is not working the way the doctor intended or prescribed.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using the online form or call 1-800-332-1088 for more information on how to mail or fax the form.

Philips Respironics recalled and then replaced specific CPAP, BiPAP and ventilator machines in 2021 and 2022 because of health risks from the breakdown of PE-PUR foam. The FDA issued a Class I recall in 2023 for many of the replacements related to faulty programming that can cause injury or death. In January 2024, Philips stopped selling its CPAP and BiPAP machines for sleep apnea in the United States.

The information on Drugwatch.com has been medically and legally reviewed by more than 30 expert contributors, including doctors, pharmacists, lawyers, patient advocates and other health care professionals. Our writers are members of professional associations, including American Medical Writers Association, American Bar Association, The Alliance of Professional Health Advocates and International Society for Medical Publication Professionals.

The 2023 recall was designated as Class I due to the risk of respiratory failure, heart failure, severe injury or death from using the replacement machines. The 2023 recall covers the replacement devices.

In December 2023, Philips agreed to settle financial claims for defective machines for $479 million dollars. The settlement reimburses people who bought, rented, or leased certain machines in the U.S. between 2008 and 2021.

The settlement does not cover injuries or death caused by the machines. A separate multidistrict litigation covers those claims. As of July 2024, there were 795 individual Philips CPAP lawsuits in a Western Pennsylvania federal court.

In 2022, the FDA issued a Class 1 recall for magnetic CPAP and BiPAP masks. Using the masks could cause serious injury or death, and they can also interfere with metallic implants. More than 18 million units in the U.S. are impacted by the recall.

The further recalls in 2023 cover models of the Philips ventilation devices named in the 2021 recall and then reworked and sent out as replacement devices. These models were incorrectly programmed and could cause injury or death.

According to the U.S. Food and Drug Administration, potential side effects related to the use of the recalled equipment include asthma, dizziness, headache, hypersensitivity reaction such as an allergic reaction or another immune system reaction, inflammatory response, irritation to the airway, nausea or vomiting, and toxic or cancer-causing effects to organs.

For details on how to remediate your Philips CPAP, BiPAP or ventilator device, check the Philips website for specific instructions based on your device series. If you have any questions, visit the Voluntary Recall section of the site.

Consult your health care provider using a recalled Philips breathing machine for any health issues. They may suggest alternatives like lifestyle changes, nasal decongestants, weight loss or sleep apnea surgery.

Philips settled a class-action lawsuit for CPAP recall in 2023. However, settlements for cancer injury claims are still pending. There are 795 Philips CPAP lawsuits consolidated in a federal MDL in Pennsylvania.

The information on this website is proprietary and protected. It is not a substitute for advice, diagnosis, treatment and other oversight responsibilities for disease processes by a credentialed physician. Any unauthorized or illegal use, copying or dissemination will be prosecuted. Please read our disclaimer for more information about our website.

According to information from the US Food and Drug Administration (FDA), some devices were assigned incorrect or duplicate serial numbers during initial programming. This duplication can cause therapy to be delivered using the wrong prescription or factory default settings. Additionally, it may fail to deliver any therapy at all. There is no warning or indication to the user that the DreamStation is not working the way the doctor intended or prescribed.

Affected devices may continue to be used in accordance with device instructions for use. At the time of this notification, Philips Respironics has not received reports of patient harm.

On Feb. 10, 2023, Philips sent affected customers and patients an Important Product Notice with the following recommendations. Products can be identified by locating the serial number of the device and verifying it against the serial numbers noted in the letter.

Via email to Sleep Review, Philips Respironics states it is reaching out to patients to set up replacement and return of affected devices. No further action is necessary by patients. To date, we are more than halfway with the shipments of replacement devices to patients.

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