Request Legal Help Now - Free

Advertisement
LAWSUITS NEWS & LEGAL INFORMATION

Two More Philips CPAP Sleep Machine Recalls

. By

Philips announced two more CPAP/ BiPAP machine recalls over two different issues—a plastic component that can release carcinogenic chemicals into the user’s airway and certain masks used with the sleep machines.

Santa Clara, CAOn the heels of its massive sleep apnea machine recall, Philips announced yet another recall but this time it involves a plastic component that can release cancer-causing chemicals into the user’s airway. Incredibly, a third and separate recall was announced on September 6, involving masks worn with the sleep machines.

The recall was announced by the FDA at the end of August. The agency states that the recalled certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines that may contain a plastic contaminated with a non-compatible material. If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). The plastic may also cause the machine to fail and stop working suddenly during use.

Although this recall is not associated with certain BiPAP machines recalled in June 2021 due to the PE-PUR foam issue, it does include some devices that were in the initial recall.  

Toxic Plastic Material


Several models of ventilators that are equipped with a “plastic contaminated with a non-compatible material may release volatile organic compounds (VOCs) directly into the machine’s air pathways,” announced the FDA. These toxic VOC’s could cause a range of health issues, from headache and dizziness to immune system reaction to toxic cancer-causing effects.

If the toxic plastic material enters the motor, the machine may abruptly shut down without warning, which means that users might not get enough oxygen pressure, which in turn can increase the risk of respiratory injuries. Or worse: if the machine suddenly stops working, the agency said it “may lead to serious injury or death.”

Philips distributed 386 affected BiPAP machines in the U.S. between Aug. 6, 2020, and Sept. 1, 2021. The company sent a recall letter to customers on Aug. 26 notifying them of the issue. 

Mask Recall


The FDA issued on September 6, 2022  yet another recall – this third recall involves over 17 million masks worn by the user when using a BiPAP or CPAP machine. The problem is a magnet that connects the mask component to hold the sleep machine in place, According to the agency,
  • The magnets can potentially affect the functioning of or cause movement of certain implanted metallic medical devices, which could result in injury or death to the mask user or people near the patient wearing the recalled mask, such as a bed partner, who have such devices. Medical devices that could potentially be affected by these magnets include brain stents, aneurysm clips, pacemakers, implantable cardioverter defibrillators, ventriculoperitoneal shunts, ocular implants, magnetic denture attachments, insulin pumps, certain neurostimulators used in and around the neck, cochlear implants or any metallic implanted medical device affected by magnets. 
  • The magnets could also affect mask users who have metallic objects in their body, such as shrapnel or splinters in their eyes, including people near the patient wearing the affected mask, such as a bed partner.
  • Five mask types are affected by this recall: the DreamWisp, DreamWear, Amara View, Wisp and Wisp Youth masks.

Serious Injuries and Deaths


As of September 6, Philips reported 14 serious injuries, including pacemaker failure, arrhythmia, seizures and irregular blood pressure related to use of the recalled masks. As of August 17th, the FDA had received reports of 44 more deaths associated with Philips Respironics’ first respiratory device recall. This update brings the number of deaths to 168. And 69,000 medical device reports (MDRs) have been related to the recall.

READ ABOUT CPAP LUNG CANCER LAWSUITS

CPAP Lung Cancer Legal Help

If you or a loved one have suffered losses in this case, please click the link below and your complaint will be sent to a drugs & medical lawyer who may evaluate your CPAP Lung Cancer claim at no cost or obligation.

ADD YOUR COMMENT ON THIS STORY

Fields marked * are mandatory. Please read our comment guidelines before posting.

*Name:

Note: Your name will be published with your comment.

*Email Address:

Your email will only be used if a response is needed.
*Your Comment:

Are you the defendant or a subject matter expert on this topic with an opposing viewpoint? We'd love to hear your comments here as well, or if you'd like to contact us for an interview please submit your details here.


Click to learn more about LawyersandSettlements.com

Request Legal Help Now! - Free