The supervision of the U.S. Food and Drug Administration (FDA) in this incident has also been called into question, with accusations that it failed to take timely action to protect patients from harm. Moreover, the DreamStation 2 CPAP ventilator, which is a replacement for the recalled devices, poses an overheating risk, potentially leading to burns, smoke, and fires.

These accusations and events have triggered public concerns about Philips Respironics and the regulatory efforts of the FDA.