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On June 26, 2021, Philips issued a Class I recall, the most serious and urgent type of recall by the FDA, for certain CPAP, BiPAP, and ventilator models due to potential degradation of sound abatement foam. Continuous positive airway pressure machines (CPAP), bilevel positive airway pressure machines (BiPAP), and ventilators are common medical devices used by patients to ensure clear, open airways and, in the case of ventilators, they maintain life.
Most important is to determine whether your CPAP, BiPAP, or a loved one’s ventilator is one of these affected devices. The easiest way to check this is to find the model name on the bottom of the machine. If you cannot find this, you can use one of two options created by Philips to first, check if you have an affected device, and second, to register your device for it to be repaired or replaced. If you are unable to find your model name, you can use the website at philipssrcupdate.expertinquiry.com or by calling 877-907-7508.
What Is Wrong With My Machine?
The defective part of these machines is the sound abatement system, made up of a polyester-based polyurethane foam. This foam, located near the motor inside the machine to dampen the noise, has been noted to degrade over time, released small particles and chemicals, which can be inhaled by the user. These chemicals, named below, are toxic and carcinogenic.
- Toluene diamine
- Toluene diisocyanate
- Diethylene glycol
- Dimethyl diazene
- Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl)
While this may be worrying, it is very important to discuss your options regarding continuing use of your machine as the potential health risks may outweigh the benefits if you discontinue use.
Philips CPAP, BiPAP, and Ventilator Recall of June 26, 2021 Information
What Are The Common Injuries?
Common associated injuries of inhalation of these gases and particles vary greatly, but include:
- Asthma
- Fibrosis
- Lung Cancer
- Any Restrictive Lung Disease (COPD, Emphysema, etc.)
- Myocardial Infarction
- Stroke
- Respiratory Arrest
- Heart Attack or Heart Failure
- Kidney Disease or Damage
- Liver Disease or Damage
- Lung Disease or Damage
- Respiratory Failure
- Reactive Airway Disease (RAD)
- Acute Respiratory Distress System (ARDS)
- Pleural Effusion
- Chemical Poisoning
- Hematopoietic Cancer
- Kidney Cancer
- Leukemia
- Liver Cancer
- Lung Cancer
- Lymphatic Cancer
- Multiple Myeloma
- Nasal Cancer
- Non-Hodgkin’s Lymphoma
Again, it is most important to discuss your options with your healthcare providers regarding continued use of your machine. For next steps in the process of holding Philips accountable for injuries related to their machines, you must have an experienced attorney by your side to fully investigate and litigate your case. If you or a loved one has used an affected device and has been injured, please contact The Simon Law Firm, P.C. today for a free, confidential consultation. Our medical device attorneys will stand by your side, support you throughout the litigation process, and work to hold Philips accountable for their wrongdoing.
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What Machines Are Impacted?
- CPAP and BiLevel PAP Devices
- Continuous Ventilator, Non-Life Supporting
- DreamStation (ASV)
- DreamStation (ST, AVAPS)
- SystemOne (ASV4)
- C Series (ASV, S/T, AVAPS)
- OmniLab Advanced Plus (In-Lab Titration Device)
- Non-Continuous Ventilator
- SystemOne (Q Series)
- DreamStation (CPAP, Auto CAP, BiPAP)
- DreamStation GO (CPAP, APAP)
- Dorma 400, 500 (CPAP)
- REMStar SE Auto (CPAP)
- Mechanical Ventilators
- Continuous Ventilator
- Trilogy 100
- Trilogy 200
- Garbin Plus, Aeris, LifeVent
- Continuous Ventilator, Minimum Ventilatory Support, Facility Use
- A-Series BiPAP V30 Auto
- Continuous Ventilator
- Continuous Ventilator, Non-Life Supporting
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