July 15, 2021
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Starting June 2021, medical device manufacturer Philips issued a voluntary recall of several sleep apnea machines and ventilators containing foam that could put users at risk of cancer or other health issues. On June 30, the FDA issued a safety warning communicating that the issues found with the affected machines “can result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent damage.”
Philips states that the defect is related to the polyester-based polyurethane (PE-PUR) sound abatement foam found in the affected devices. The foam in question can degrade over time and emit chemical particles when cleaned improperly or exposed to high heat, leading to potentially harmful effects on the user. The following devices have were included in the voluntary recall:
- CPAP & Bi-PAP Devices
- E30
- DreamStation
- DreamStation Go
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C-Series ASV
- C-Series S/T and AVAPS
- OmniLab Advanced+
- SystemOne (Q-Series)
- Dorma 400 + 500
- REMstar SE Auto
- Ventilators
- Trilogy 100 + 200
- Garin Plus, Aeris, LifeVent
- A-Series BiPAP Hybrid A30
- A-Series BiPAP V30 Auto
- A-Series BiPAP A40 + A30
Although Philips said that there have been no reports of deaths, they have acknowledged that the recall is based, in part on potential carcinogenic risk. The company has also indicated that there is a potential for risks from toxic or chemical exposure including headaches, irritation, inflammation, hypersensitivity, nausea/vomiting, respiratory issues, and other possible carcinogenic effects.
Patients currently using any of the machines mentioned in the recall are advised to cease usage of the devices and consult with their doctors about whether to adjust their current treatment plans. In some cases, the benefits of continuing to use the devices “may outweigh the risks,” says Philips.
If you have been injured due to the Philips defective ventilators, BiPAP, or CPAP machines, contact Cellino Law for a free case consultation. Our team of attorneys have represented many clients who have been wronged by medical device and pharmaceutical companies. We have the experience needed to face these massive medical device companies on your behalf and will be there every step of the way to ensure that you get the compensation you deserve.