Philips announced a voluntary recall of some of its sleep and respiratory care devices in mid-June. The U.S. Food and Drug Administration (FDA) announced the recall was issued for multiple devices, based on the risk of injury.

The FDA has not classified this recall. However, on June 30, the FDA issued a Safety Communication stating, “These issues can result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent damage.” (1)

The devices recalled include these products manufactured by Philips:

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

The recall instructs patients, “To continue use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks identified in the recall notification.” (2)

The potential health risks are related to the sound abatement foam component used in the devices. They are made of polyester-based polyurethane (PE-PUR).

Through testing, Philips determined the foam used in the devices poses possible risks to users. If the foam degrades, particles may be swallowed or inhaled via the device’s air pathway. Certain chemical gases may also be given off.

According to Philips, possible injuries from recalled products fall into these categories:

  • Carcinogenic effects.
  • Toxic effects.
  • Respiratory issues.
  • Chemical exposure risk.

Additional risks of exposure to the particles include headache, irritation, and inflammation. Other off-gassing risks include headache, irritation, hypersensitivity, nausea and vomiting.

W&L Accepting PAP, CPAP and Ventilator Cases

Weitz & Luxenberg is now accepting potential cases from individuals who were injured, or whose loved ones died, after utilizing these recalled medical devices. Please reach out to us if you have been diagnosed with any of these illness after using a Philips PAP, CPAP or ventilator.

Cancer

Philips has indicated the devices recall is based, in part, on potential carcinogenic risk. Cancers we are accepting for investigation include:

  • Bladder Cancer
  • Brain Cancer
  • Breast Cancer
  • Hematopoietic (Blood) Cancer
  • Kidney Cancer
  • Leukemia
  • Liver Cancer
  • Lung Cancer
  • Lymphatic Cancer
  • Multiple Myeloma
  • Nasal Cancer
  • Non-Hodgkin Lymphoma
  • Papillary Carcinoma
  • Prostate Cancer
  • Rectal Cancer
  • Stomach Cancer
  • Testicular Cancer
  • Thyroid Cancer

Other Serious Injuries

Philips has also indicated there is a potential for risks from toxic or chemical exposure. Respiratory issues may also occur. These risks could include:

  • Lung/Pulmonary Damage
  • Pleural Effusion
  • Lung/Pulmonary Disease
  • Kidney/Renal Damage
  • Kidney/Renal Disease
  • Liver Damage
  • Liver Disease
  • Reactive Airway Disease (RAD)
  • Acute Respiratory Distress System (ARDS)
  • Respiratory Failure
  • Chemical Poisoning
  • Severe Ear Inflammation
  • Severe Nose Inflammation
  • Severe Throat Inflammation

Recalled Devices

According to Philips, “The majority of the affected devices within the advised 5-year service life are in the first-generation DreamStation product family.” (3)

Philips list of the types of recalled devices include: (4)

CPAP and BiLevel PAP Devices

All affected devices manufactured before 26 April 2021, all device serial numbers:

  • Continuous Ventilator, Minimum Ventilatory Support, Facility Use.
  • Continuous Ventilator, Non-life Supporting.
  • Non-continuous Ventilator.

Mechanical Ventilators

All affected devices manufactured before 26 April 2021, all device serial numbers:

  • Continuous Ventilator.
  • Continuous Ventilator, Minimum Ventilatory Support, Facility Use.
  • Continuous Ventilator, Non-life Supporting.

What Is a Ventilator? CPAP? BiPAP?

Mechanical ventilators help people “breathe when they find it difficult or are unable to breathe on their own. A mechanical ventilator pushes airflow into the patient’s lungs to help them breathe.” (5)

“A continuous positive airway pressure (CPAP) machine is the most commonly prescribed device for treating sleep apnea disorders.” It “sends a steady flow of oxygen into your nose and mouth as you sleep. This keeps your airways open and helps you breathe normally.” (6)

CPAP devices are “programmed to produce pressurized air at one steady air pressure level. To change the air pressure, you have to reset the device’s settings.” (7)

A BiPAP (Bi-level positive airflow pressure) is similar, but “has two pressure settings, one pressure for inhaling and a lower pressure for exhaling.” (8)

Voluntary Recall Issued

On June 14, 2021, manufacturer Philips issued a voluntary recall. It was published on the FDA website on the following day, June 15. The FDA listed the Company Announcement from Philips under its website section for Recalls, Market Withdrawals, & Safety Alerts.

The concern with these devices was raised in the Philips Quarterly Report in April, 2021. In it, the company offers a regulatory update indicating, “Philips has determined from user reports and testing that there are possible risks to users related to the sound abatement foam used in certain of Philips’ sleep and respiratory care devices currently in use. The risks include that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods… and certain environmental conditions involving high humidity and temperature.” (9)

W&L Helping People Injured by Philips Devices

“Our firm is interested in helping you if you, or a loved one, experienced a serious health injury after using one of the recalled Philips medical devices,” says Ellen Relkin, chair of Weitz & Luxenberg’s Drug and Medical Device Litigation practice group.

She continues, “Medical devices that do not function correctly put people at risk. These defective devices are supposed to help people – not harm them. Manufacturers who caused you to suffer a serious injury should pay you compensation.”

You may be able to receive compensation for:

  • Costs of doctor visits, medicines, nursing care and other medical expenses.
  • Any money you lost in wages because you missed days of work.
  • Future income if you can’t go back to work due to your injury.
  • Pain and suffering.

Winning for Our Clients

Our attorneys go up against the manufacturers of defective medical devices in lawsuits time and time again. We have a successful record of winning for our clients – $12 billion in verdicts and settlements.

Ms. Relkin has helped thousands of injured patients during her extensive legal career. She believes strongly in representing people hurt by defective medical devices. As the court appointed lead counsel, she helped secure a multibillion dollar settlement on behalf of recipients of the recalled DePuy ASR hip implant and a $1+ billion settlement, as part of the team, for Stryker Rejuvenate and ABGII modular hip implants defects.

Our medical device team of attorneys is ready to assist you. One of the attorneys on the W&L medical device team is also a medical engineer. We offer a free consultation to discuss your legal options.

  1. U.S. Food & Drug Administration. (2021, June 30). Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. Retrieved from https://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health-risks
  2. U.S. Food & Drug Administration. (2021, June 15). Philips Issues a Recall Notification* to Mitigate Potential Health Risks Related to the Sound Abatement Foam Component in Certain Sleep and Respiratory Care Devices. Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/philips-issues-recall-notification-mitigate-potential-health-risks-related-sound-abatement-foam
  3. Ibid.
  4. Philips. (n.d.) Medical Device recall notification (U.S. only) / field safety notice (International Markets). Philips Respironics. Retrieved from https://www.usa.philips.com/healthcare/e/sleep/communications/src-update
  5. MedicineNet. (2020, March 31) What Are the Different Types of Mechanical Ventilation? Retrieved from https://www.medicinenet.com/different_types_of_mechanical_ventilation/article.htm
  6. Healthline. (2020, August 18). What’s a CPAP Machine, and How Does It Work? Retrieved from https://www.healthline.com/health/what-is-a-cpap-machine
  7. Ibid.
  8. Ibid.
  9. Koninklijke Philips N.V. (2021, April 26) Philips. Q1, 2021. Quarterly Report. Retrieved from https://www.results.philips.com/publications/q121/downloads/pdf/en/philips-first-quarter-results-2021-report.pdf

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