Philips (NYSE:PHG) stock was trading higher premarket Tuesday after the company said risk assessments were completed for ~95% of recalled sleep devices and that they do not pose any “appreciable harm” to the patients.
The company has been reeling under the impact of recall of certain of its respiratory devices due to potential safety issues since June 2021.
The tests were carried out to to assess the potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in specific sleep therapy and ventilator devices, according to Philips.
The Dutch company said test results for the first-generation DreamStation, System One and DreamStation Go sleep therapy devices suggest that potential patient exposure to foam particulate matter (PM) and volatile organic compounds (VOCs) from the PE-PUR foam in the devices is unlikely to result in an appreciable harm to health in patients.
The test and research program was carried out with five independent testing laboratories, and the results were reviewed by third-party experts and Philips Respironics, the company added.
“The third-party risk assessments for the sleep therapy devices presented today are positive and reassuring, and we are making good progress with the remediation of the affected devices. The relevant competent authorities globally, including the FDA, are still reviewing the test results and assessments,” said Royal Philips CEO Roy Jakobs.
In February, the U.S. FDA had classified the recall of certain reworked Philips ventilators as the most serious type, class 1, because their use may cause serious injuries or death.
In April, Philips also clarified its product recall related to certain respiratory devices after the FDA warned that the number of replaced or repaired products was considerably less than the company’s publicly disclosed numbers.
The company has set aside around €1B for the recall of around 5.5M devices globally, according to a Bloomberg report. In addition, in Q1 Philips made a €575M litigation provision related to the expected resolution of the Respironics recall-related economic loss class action in the U.S.
Philips is facing several lawsuits related to alleged safety issues. In March Jakobs said the company expects to reach settlements on economic damages this year however, settlement with patients who allege that the use of the recalled devices made them sick is expected to take longer.
PHG +2.65% to $21.32 premarket May16