FDA Publishes a New Warning Concerning the Philips Breathing Machine Recall
According to a news report on foxbusiness.com, the U.S. Food and Drug Administration (FDA) issued a new warning notice to patients who use Philips Respironics breathing machines. The notice states that some patients and medical suppliers said they were unaware of the breathing assistance machine recall. Last summer, Philips Respironics certain continuous positive airway pressure (CPAP), ventilators, and bilevel positive airway pressure (BiPAP) machines were recalled due to health concerns. The recall states that the sound abatement foam can disintegrate and release toxic chemicals that are then breathed in by the user. The toxic fumes can cause cancers. According to the FDA’s recall announcement, the sound abatement foam can cause serious injury, life-threatening injuries, permanent impairment, and could require medical treatment to prevent permanent injury.
The FDA is ordering Philips to advise all affected device users, distributors, medical equipment suppliers, health care providers, and retailers about the recall and its “unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in those products.”
The order also requires Philips to notify patients about the risks connected to ozone cleaner use on the recalled breathing machines. Philips is also ordered to provide instructions to users on registering their devices on the Philips website.
The FDA states that Philips’ notification efforts have been inadequate and Philips should also provide monthly updates to breathing device users who registered their breathing devices. The update should also include information about the replacement process.
The list of the recalled breathing machine includes the following products manufactured between 2009 and April 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 ASV
- DreamStation Go
- DreamStation ST, AVAPS
- Dorma 400
- Dorma 500
- Garbin Plus, Aeris, LifeVent (ventilator)
- OmniLab Advanced+
- REMstar SE Auto
- SystemOne ASV4
- SystemOne (Q-Series)
- Trilogy 100 (ventilator)
- Trilogy 200 (ventilator)
Philips has also recalled some Trilogy Evo ventilators that were sold from April 15, 2021 to May 24, 2021.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
Did you or a loved one suffer harm due to a defective vehicle? Parker Waichman LLP helps those who have suffered injuries after using defective vehicles receive full monetary compensation. Trust your case with our product liability lawsuit lawyers. For a free consultation, contact our law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
New York | Brooklyn | Queens | Long Island | New Jersey | Florida
Call us at: 1-800-YOURLAWYER (800-968-7529) | Schedule your free consultation