On June 14, 2021, Philips Respironics recalled certain continuous positive airway pressure (CPAP) machines, ventilators, and bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines because of potential health risks.1 Most of these machines were used by patients to treat obstructive sleep apnea and other breathing difficulties while asleep. The Philips Respironics recall is a Class I recall, the most serious type of recall. Specifically, Class I recalls have a reasonable probability of causing serious adverse health consequences or death.
According to Philips, these recalled devices contain polyester-based polyurethane sound abatement foam (“PE-PUR Foam”) that may degrade or off-gas with use or while cleaning. The potential risks of inhaling chemicals from the PE-PUR Foam includes toxic or cancer-causing effects to organs such as kidneys and liver.2 Other respiratory injuries include inflammatory response, asthma, and a hypersensitivity reaction.3 Philips reported to physicians that PE-PUR Foam particles “may cause irritation and airway inflammation, and this may be particularly important for patients with underlying lung diseases or reduced cardiopulmonary reserve.”4
Nationally, there are approximately 3 to 4 million devices affected by the Philips recall.5 These recalled devices include the following devices made between 2009 and April 26, 2021:
- A-Series BiPAP A30
- A-Series BiPAP A40 (ventilator)
- A-Series BiPAP Hybrid A30
- A-Series BiPAP V30 Auto (ventilator)
- C-Series ASV (ventilator)
- C-Series S/T and AVAPS
- DreamStation
- DreamStation ASV
- DreamStation Go
- DreamStation ST, AVAPS
- Dorma 400
- Dorma 500
- E30
- Garbin Plus, Aeris, LifeVent (ventilator)
- OmniLab Advanced+
- REMstar SE Auto
- SystemOne ASV4
- SystemOne (Q-Series)
- Trilogy 100 (ventilator)
- Trilogy 200 (ventilator)
For patients who are using its Bilevel PAP and CPAP machines, Philips is advising that they discontinue and consult with their physicians to determine the benefits of continuing therapy and potential risks.6 For patients using Philips’ life-sustaining mechanical ventilators, Philips advised that they “DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps.7
Shortly after the recall, Glenn Danas, Esq., from Robins Kaplan filed consumer class action claims to seek recovery for the losses sustained by all purchasers and users of recalled devices, as well as medical monitoring damages, where applicable. Present in all these actions is whether the millions of recalled devices are now rendered worthless because of the degradation and off-gassing of the PE-PUR Foam. In addition, our national mass tort practice group is actively investigating injuries related to these recalled devices, including cancer and respiratory claims.
Robins Kaplan welcomes the opportunity to discuss these recalled devices for class action and/or personal injury claims further with your law firm, as well as any potential client referrals. Please contact our New York mass tort partner, Rayna E. Kessler, Esq., at 212.980.7431 or RKessler@RobinsKaplan.com.
1 https://www.fda.gov/medical-devices/safety-communications/philips-respironics-cpap-bipap-and-ventilator-recalls-frequently-asked-questions
2 https://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health
3 Id.
4 Philips Sleep and Respiratory Care Update – Clinical information for physicians, June 14, 2021, philipsrecall-clinical-information-for-physicians-and-providers.pdf (accessed June 27, 2021).
5 Associated Press, Philips recalls ventilators, sleep apnea machines due to health risks, NBC NEWS, https://www.nbcnews.com/business/consumer/philips-recalls-ventilators-sleep-apnea-machines-duehealth-risks-n1270725 (accessed June 27, 2021).Medical Device recall notification (U.S. only) / field safety notice (International Markets), PHILIPS RESPIRONICS (June 14, 2021), https://www.usa.philips.com/healthcare/e/sleep/communications/srcupdate#section_2 (accessed June 27, 2021) (Questions and answers).
6 Id.
7 Id.
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