Philips Respironics initiated a recall and replacement program for specific CPAP, BiPAP, and ventilator machines in 2021 and 2022 due to health risks associated with the breakdown of PE-PUR foam. Subsequently, the FDA issued a Class I recall in 2023 for many of the replacement devices due to faulty programming that could result in injury or death. As of January 2024, Philips ceased the sale of its CPAP and BiPAP machines for sleep apnea in the United States.
Latest Philips CPAP Machine Recalls
The FDA’s Class I recall in 2023 encompassed certain Philips CPAP and respiratory devices, following an earlier 2021 recall for specific models. Despite reworking and replacing many of the recalled machines, issues persisted, necessitating further action. The 2023 recall was classified as Class I due to the potential risks of respiratory or heart failure, severe injury, or death associated with the replacement machines.
CPAP Recall Updates Timeline
- June 2021: Philips issued a voluntary recall for some CPAP, BiPAP, and ventilator models due to reports of disintegrating sound abatement foam.
- September 2021: Philips initiated a repair-and-replace program covering all recalled CPAP, BiPAP, and ventilator devices from 2021.
- November 2021: The FDA flagged a safety issue with silicone-based foam in Philips devices, suggesting long-standing foam-related problems.
- March 2022: The FDA notified Philips of inadequate consumer notification regarding the 2021 recall.
- August 2022: Philips recalled approximately 1,660 BiPAP devices due to potential toxic fume release or device failure.
- November 2022: The FDA received over 90,000 reports concerning Philips breathing devices related to the breakdown of sound abatement foam.
- December 2022: The FDA released a safety bulletin regarding certain remediated models of Philips breathing devices, highlighting ongoing concerns.
- April 2023: Philips recalled more than 1,000 replacement CPAP and BiPAP machines.
- June 2023: The FDA received over 100,000 medical device reports related to previously recalled Philips breathing devices, prompting further action.
- December 2023: Philips agreed to a $479 million reimbursement settlement for people affected by the recall between 2008 and 2021.
Philips Replacements and Financial Settlement
The $479 million settlement, reached in December 2023, reimburses individuals who bought, rented, or leased certain machines between 2008 and 2021. However, the settlement does not cover injuries or deaths caused by the machines, which are addressed in a separate multidistrict litigation. As of February 2024, there were 760 individual Philips CPAP lawsuits in a Western Pennsylvania federal court.
Current Status
Philips has distributed 2.46 million reworked CPAP replacement devices and repair kits, but the FDA notes that the number of replacement devices is insufficient. Millions of people may have been affected by a Philips CPAP replacement shortage. Individuals awaiting a remediated device are advised to contact Philips for updates.
Philips CPAP, BiPAP, and Ventilator Recall Overview
Philips issued recalls for certain models of CPAP, BiPAP, and ventilator machines in 2021, 2022, and 2023 due to various health risks. The recall primarily affects machines from the Philips DreamStation line. Notably, the FDA issued a Class 1 recall in 2022 for magnetic CPAP and BiPAP masks, impacting over 18 million units in the U.S.
Recalled Models of Philips CPAP, BiPAP, and Ventilators
The recalled models include machines from the DreamStation line, as well as other specific models such as A-Series BiPAP A30, A40, Hybrid A30, V30 Auto, C-Series ASV, C-Series S/T and AVAPS, Dorma 400, Dorma 500, E30, Garbin Plus, Aeris, LifeVent, OmniLab Advanced+, REMstar SE Auto, SystemOne ASV4, SystemOne (Q-Series), and Trilogy 100 and Trilogy 200.
Recalled Models of Philips Magnetic CPAP Masks
The FDA’s recall in 2022 included models such as Amara View Full Face Mask, DreamWear Full Face Mask, DreamWisp Nasal Mask, Therapy Mask 3100 NC/SP, and Wisp and Wisp Pediatric Nasal Mask.
Reasons for Recalls
- 2021 Recall: Due to disintegration and toxicity risks from PE-PUR foam in the devices.
- 2022 Recall: Concerns over the toxicity of plastic parts inside the machines.
- 2023 Recall: Programming errors in replacement or reworked models from the 2021 recall.
FDA Reports and Side Effects
From April 2021 to the 2023 recall, the FDA received over 105,000 medical device reports, including 385 death reports, linked to PE-PUR foam breakdown. Potential side effects related to the use of the recalled equipment include asthma, dizziness, headache, hypersensitivity reactions, inflammatory responses, irritation to the airway, nausea or vomiting, and toxic or cancer-causing effects to organs.
