Philips released an update related to the recall of one of its sleep apnea devices, indicating that health risk concerns relating to the recall may not have been as serious or widespread as previously believed.
Philips contends that there is “a very low prevalence of visible foam degradation” in certain sleep apnea devices following a visual assessment of nearly 61,000 machines, the same devices affected by the company’s ongoing recall.
The company, which released results from the assessment Tuesday, claims that about 2% of the 60,847 devices examined showed visible foam degradation or volume reduction. The assessment was done on first-generation DreamStation machines, which make up the bulk of the company’s recall of millions of sleep apnea and ventilator devices.
Read the full story at MedTech Dive.