Question 1

What is wrong with SoClean?

Accepted Answer

According to allegations raised in SoClean lawsuits, the use of unsafe and unacceptably high levels of ozone to sanitize CPAP machines is the root cause of what is wrong with SoClean.  To effectively destroy harmful material, SoClean devices pump ozone throughout the inside of the sleep apnea machine for seven to 14 minutes, indicating that it “kills up to 99.9% of germs and bacteria that can build up in CPAP and BiPAP equipment without having to disassemble the devices.”

Question 2

Is the Ozone in SoClean safe?

Accepted Answer

As a result of the health risks from ozone cleaners, the FDA regulations make it illegal for any medical device to generate or cause the accumulation of ozone in levels exceeding .05 parts per million by volume of air “in the atmosphere of an enclosed space intended to be occupied by people for extended periods of time,” such as houses, apartments or even hospitals.  SoClean class action lawsuit allegations indicate that the CPAP sanitizing devices generate ozone at levels of about 30 parts per million, by volume of air circulating through the device during a cleaning cycle. This could make SoClean ozone unsafe when used in minimally ventilated spaces, such as a small bathroom. Also, some reports suggest that elevated levels of ozone are commonly found inside CPAP tubing, even after waiting the recommended time after cleaning with products that do not perform an automatic clean air purge toward the end of the ozone cleaning cycle.

Question 3

Is the SoClean ozone bad for your lungs?

Accepted Answer

Ozone gas used by SoClean CPAP devices is known to be toxic to humans at high levels, posing serious risks for your lungs after prolonged exposure or high concentrations. While the ozone CPAP cleaners are marketed as “safe”, SoClean lawsuit allegations indicate that false and misleading information has been provided about whether ozone in SoClean is bad for your lungs.  There are several known human health risks associated with exposure to high levels of ozone, which is the primary ingredient in “smog”, along with particulate matter. As a result, many cities monitor ozone levels regularly and sometimes announce “ozone alerts” or “ozone action days”, when ozone levels exceed what is considered safe.

Question 4

Did the FDA issue a SoClean Recall?

Accepted Answer

No. As of late 2021, the FDA is continuing to work with SoClean and manufacturers to review testing data and determine whether it is appropriate to allow the continued use of ozone CPAP cleaners. However, the FDA has not issued a SoClean recall.

Question 5

Is SoClean responsible for Philips Recall?

Accepted Answer

No. The Philips CPAP recall can not be blamed on SoClean alone, and the real reason Philips recalled DreamStation machines was a defective and unreasonably dangerous design. While the use of SoClean or other ozone cleaners may impact the rate at which the Philips CPAP foam degrades, so do other factors, including high heat or humidity. In fact, the PE-PUR foam has been found to release harmful chemicals and gasses right out of the box, and problems have been reported by individuals who never owned or used SoClean with their Philips DreamStation CPAP machine.

Question 6

Why did SoClean sue Philips?

Accepted Answer

On October 12, 2021, a SoClean lawsuit was filed against Philips Respironics, alleging that the CPAP manufacturer was trying to use SoClean devices as a scapegoat for possible health problems caused by Philips’ use of PE-PUR sound abatement foam.

Question 7

Does SoClean void a CPAP warranty?

Accepted Answer

Philips has issued a statement in the past indicating that the use of a SoClean device does not necessarily void the warranty on one of their CPAP machines. However, the company indicates it reserves the right to void the warranty if the use of SoClean causes a defect which led to the return of a CPAP device still under warranty. Regardless of whether the manufacturer attempts to argue that SoClean voided a DreamStation warranty, use of the ozone cleaning product will not allow the company to escape liability for selling a dangerous CPAP machine with defective sound abatement foam that has left users with permanent lung damage, cancer and other injuries.

Question 8

Will SoClean lawsuits impact Philips CPAP recall claims?

Accepted Answer

The Philips DreamStation lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who are pursuing lawsuits over long-term injuries and side effects from the CPAP sound abatement foam.

Question 9

How is the SoClean Lawsuit related to the CPAP recall lawsuit?

Accepted Answer

Allegations raised in the SoClean lawsuit often cause confusion for some owners of recalled Philips DreamStation CPAP machines, which contain a polyester-based polyurethane (PE-PUR) sound abatement foam that has been found to breakdown and release toxic particles directly into the user’s air pathways. Since the recall, Philips Respironics has made several statements that suggested the use of ozone cleaning systems may exacerbate the CPAP foam breakdown, leading to questions about whether SoClean is responsible for the Philips DreamStation recall.

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