Philips found low health risk in test of recalled apnea devices

Tests show emissions from degraded foam aren’t expected to cause long-term health consequences for patients whose DreamStation devices haven’t been exposed to ozone cleaning, the Netherlands-based health company said in a Wednesday statement on its recalled ventilator devices.

Philips shares gained as much as 5.5%, the most since Nov. 11, and were trading 3.2% higher at 12.802 euros as of 10:04 a.m. local time. They are still down more than 60% so far this year.

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Philips initiated its first recall of potentially faulty sleep apnea products in June 2021, with the US Food & Drug Administration also labeling those as a Class 1 issue. The company has made cumulative financial provisions of around €885 million ($940 million) for the recall of affected devices and has warned it might need to increase the money it sets aside as user lawsuits progress.

ING analyst Marc Hesselink said that while the results don’t take away from the litigation risk, the test outcomes lower the risk of very high claims per patient. 

Testing has shown emissions are “within safety limit,” Philips Chief Executive Roy Jakobs said in a phone interview. That is very “encouraging and reassuring news” for the patients, he said.

Philips expects that next year the litigation process will “get more clearer” in due course, Jakobs added. “Today’s update will feed into that process.”

The FDA is still considering the data provided by the company and Philips acknowledged that the health authority may reach different conclusions.

This story has been published from a wire agency feed without modifications to the text.