Millions of people suffering from sleep apnea and using a respiratory device made by Philips should be made aware of the continued potential for serious health concerns.
Philips recalled certain ventilators, continuous positive airway pressure (CPAP), and bilevel positive airway pressure (BiPAP) machines this past June and then began to repair or replace many of their devices. However, the FDA now has concerns about the repairs and newer devices as well.
The June recall (https://bit.ly/CPAPrecalls) is based upon a silicone-based foam that is known to break down and release toxic and possibly carcinogenic substances. Philps has cited numerous reasons for the foam to come apart, including humidity levels or the use of certain cleaning agents. There are allegations that Philips has known of the problems and possible dangerous health impacts for a long time, yet delayed informing the public and the FDA.
In its statement announcing the recall, the FDA warns consumers, “The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.”
Some of the health issues include the possibility of:
[If you or a loved one are suffering from health issues and used one of the recalled devices, it is important for you to seek an experienced legal team before time runs out. For a free evaluation of your potential case, contact the Cohen Hirsch Law Firm.]
After the recall, Philips Respironics and the FDA agreed upon a plan for the recalled CPAP and BiPAP devices to be repaired with a different, silicone-based foam. However, after inspecting a Philips manufacturing plant, the FDA has new questions on whether the repairs may also pose a risk to patients. Though, the FDA says customers who have recent repairs or replacements from Philips should continue to use them until further information is available. Of note, it is still the recommendation of the FDA that other patients who have a recalled machine should either switch to another product, stop using it, or consult with the doctor on whether it should be used.
For a list of which products are affected (along with those that are not part of the recall), Philips has details here: https://bit.ly/CPAPrecalls
To read the details of the FDA’s updated concerns about Philips’ repairs and the continued possible health risks: https://bit.ly/CPAPrecallFDA
CPAP and other breathing assistance machines made by Philips are recalled due to health concerns.